Product Code: DXT FDA class 2 21 CFR 870.1650

Injector And Syringe, Angiographic

Cardiovascular

The Angiographic Injector and Syringe is a cardiovascular device used to deliver contrast media rapidly and precisely into blood vessels during angiographic imaging procedures, enabling visualization of vascular anatomy. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is DXT and the applicable regulation is 21 CFR 870.1650, under the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

205

FEI Numbers

120

Registration Numbers

120

Unique Applicants

Years Active

Basic Information

Product Code: DXT
Device Class: FDA class 2
Regulation Number: 870.1650
Medical Specialty: Cardiovascular
Review Panel: HO
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 205 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242143	Angiography Injector	Dec 23, 2024	Substantially Equivalent	Shandong INT Medical Instruments Co., Ltd.
K242212	Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)	Aug 27, 2024	Substantially Equivalent	Nemoto Kyorindo Co., Ltd.
K241109	Single-use Sterile High-pressure Angiographic Syringes and Accessories	Aug 22, 2024	Substantially Equivalent	Shenzhen Boon Medical Supply Co., Ltd.
K230668	Disposable High-pressure Extension Lines	Jun 14, 2024	Substantially Equivalent	Precision Medical Plastics Ltd.
K232388	High Pressure Tubing	Nov 21, 2023	Substantially Equivalent	Ningbo DIZEGENS Medical Science Co., Ltd.
K211564	Sterile High-pressure Angiographic Syringes for Single-use	Oct 19, 2021	Substantially Equivalent	Shenzhen Boon Medical Supply Co., Ltd
K203004	ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System	Dec 17, 2020	Substantially Equivalent	ACIST Medical Systems, Inc.
K201395	Sterile High-pressure Angiographic Syringes for single-use	Oct 28, 2020	Substantially Equivalent	Youwo (Guangzhou) Medical Device Co., Ltd.
K192657	Sterile High-pressure Angiographic Syringes for Single-use	Aug 07, 2020	Substantially Equivalent	Shenzhen Boon Medical Supply Co., Ltd
K192370	MEDRAD Stellant FLEX CT Injection System with Certegra Workstation	Dec 13, 2019	Substantially Equivalent	Bayer Medical Care, Inc.
K193028	MEDRAD Mark 7 Arterion Injection System	Dec 05, 2019	Substantially Equivalent	Bayer Medical Care Inc.
K190102	DyeVert Plus Contrast Reduction System, DyeTect Contrast Monitoring System, DyeVert Plus EZ Contrast Reduction System	Oct 17, 2019	Substantially Equivalent	Osprey Medical Inc.
K191060	ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit	Jul 18, 2019	Substantially Equivalent	ACIST Medical Systems, Inc.
K183267	DyeVert NG Contrast Reduction System, DyeVert PLUS EZ Contrast Reduction System, DyeTect Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert PLUS EZ Contrast Reduction System	Dec 20, 2018	Substantially Equivalent	Osprey Medical, Inc.
K182276	MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit	Nov 01, 2018	Substantially Equivalent	Bayer Medical Care Inc.
K182273	MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT	Nov 01, 2018	Substantially Equivalent	Bayer Medical Care Inc.
K181936	DyeVert PLUS EZ Contrast Reduction System	Oct 25, 2018	Substantially Equivalent	Osprey Medical, Inc.
K182289	Sterile High-pressure Angiographic Syringes for Single-use	Oct 10, 2018	Substantially Equivalent	Shenzhen Baoan Medical Supplies Co., Ltd
K173773	MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT	Aug 17, 2018	Substantially Equivalent	Bayer Medical Care Inc.
K172694	Sterile Disposable Syringes	Jul 06, 2018	Substantially Equivalent	Shenyang MasTech Medical Device Co., Ltd.
K171646	ACISTCVi® Contrast Delivery System	Feb 16, 2018	Substantially Equivalent	ACIST Medical Systems, Inc.
K173450	PRESS DUO elite, PRESS DUO elite AG	Feb 07, 2018	Substantially Equivalent	Nemoto Kyorindo Co., Ltd.
K170279	Disposable High Pressure Syringe	Dec 12, 2017	Substantially Equivalent	Union Medical Shenzhen Co., Ltd.
K170014	High Pressure Tubing	Oct 06, 2017	Substantially Equivalent	SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.
K170025	Angiography Syringe	Oct 03, 2017	Substantially Equivalent	SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.
K170431	CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip	Aug 18, 2017	Substantially Equivalent	Coeur, Inc.
K171698	Smart Syringe	Jul 07, 2017	Substantially Equivalent	Osprey Medical, Inc.
K163084	Merit Coronary Control Syringe	Jun 15, 2017	Substantially Equivalent	Merit Medical Systems, Inc.
K171217	DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System	May 26, 2017	Substantially Equivalent	Osprey Medical, Inc.
K163054	DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System	Mar 08, 2017	Substantially Equivalent	OSPREY MEDICAL, INC.
K162088	Ecomed Disposable Angiographic Syringes	Jan 27, 2017	Substantially Equivalent	ECOMED SOLUTIONS, LLC
K152906	Disposable High Pressure Injector Syringe	Nov 22, 2016	Substantially Equivalent	WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
K160190	Sunmed Control Syringes	Nov 10, 2016	Substantially Equivalent	Sunny Medical Device (Shenzhen) Co.,Ltd.
K161471	MR Syringe Dual Pack for Solaris Injectors	Oct 06, 2016	Substantially Equivalent	Coeur, Inc.
K161505	DyeVert NG Contrast Modulation System	Aug 03, 2016	Substantially Equivalent	OSPREY MEDICAL, INC.
K160107	DiamondTOUCH Inflation Device and Fluid Dispensing Syringe	Jul 29, 2016	Unknown	Merit Medical Systems, Inc.
K152978	DeRoyal Angiography Kits	Mar 25, 2016	Unknown	DEROYAL INDUSTRIES, INC.
K153141	DyeVert Contrast Modulation System	Feb 04, 2016	Substantially Equivalent	OSPREY MEDICAL, INC.
K151960	Sterile High-pressure Angiographic Syringes for Single-use	Jan 07, 2016	Substantially Equivalent	SHENZHEN BAOAN MEDICAL SUPPLIES CO., LTD
K150902	330psi Extension Y-Line with Dual Check Valve	Oct 22, 2015	Substantially Equivalent	COEUR, INC.
K151300	AVERT Contrast Modulation System	Oct 15, 2015	Substantially Equivalent	OSPREY MEDICAL, INC.
K151746	Dyevert Contrast Modulation System	Oct 09, 2015	Substantially Equivalent	OSPREY MEDICAL, INC.
K152218	AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation System	Sep 21, 2015	Substantially Equivalent	Osprey Medical
K143538	MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit	Aug 14, 2015	Substantially Equivalent	BAYER MEDICAL CARE INC.
K142745	125mL CT Syringe	Apr 01, 2015	Substantially Equivalent	COEUR, INC.
K150485	AVERT Contrast Modulation System	Mar 26, 2015	Substantially Equivalent	Osprey Medical, Inc.
K142081	CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES	Dec 12, 2014	Substantially Equivalent	OSPREY MEDICAL, INC.
K140469	MR SYRINGE DUAL PACK	Jul 28, 2014	Substantially Equivalent	COEUR, INC.
K133189	DUAL SHOT ALPHA 7	Jun 30, 2014	Substantially Equivalent	NEMOTO KYORINDO CO., LTD.
K140425	CONTRAST MODULATION SYSTEM	Jun 11, 2014	Substantially Equivalent	OSPREY MEDICAL, INC.
K133600	COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR	Apr 30, 2014	Substantially Equivalent	COEUR, INC.
K132928	MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE	Jan 23, 2014	Substantially Equivalent	MEDRAD, INC. / BAYER MEDICAL CARE, INC.
K131478	CONTRAST CONSERVATION SYSTEM	Aug 15, 2013	Substantially Equivalent	OSPREY MEDICAL, INC.
K120892	DISPOSABLE 330PSI EXTENSION LINES	Jun 10, 2013	Substantially Equivalent	COEUR, INC.
K113133	MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE	Dec 15, 2011	Substantially Equivalent	MEDRAD, INC.
K113198	NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML	Nov 28, 2011	Substantially Equivalent	NAVILYST MEDICAL, INC.
K112086	MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE	Oct 14, 2011	Substantially Equivalent	MEDRAD, INC.
K093830	MEDLINE ANGIOGRAPHIC CONTROL SYRINGE	Mar 03, 2011	Substantially Equivalent	MEDLINE INDUSTRIES, INC.
K092896	REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS	Oct 29, 2010	Substantially Equivalent	NEMOTO KYORINDO CO., LTD.
K090487	DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150	Oct 19, 2009	Substantially Equivalent	COEUR, INC.
K090621	FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100	Jun 19, 2009	Substantially Equivalent	FLOWCARDIA, INC.
K082439	DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT	Mar 23, 2009	Substantially Equivalent	SHANDONG WEIGAO MEDICAL POLYMER CO., LTD
K083523	MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE	Feb 04, 2009	Substantially Equivalent	MERIT MEDICAL SYSTEMS, INC.
K082212	SYRINGE WITH HANDI-FIL	Jan 22, 2009	Substantially Equivalent	MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
K082905	MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC	Jan 12, 2009	Substantially Equivalent	MEDRAD, INC.
K073592	OPTISTAR ELITE INJECTION SYSTEM	May 07, 2008	Substantially Equivalent	MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
K072696	ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301	May 02, 2008	Substantially Equivalent	SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD
K072886	MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T	Dec 21, 2007	Substantially Equivalent	MEDRAD, INC.
K071691	DUAL SHOT ALPHA	Dec 19, 2007	Substantially Equivalent	NEMOTO KYORINDO CO., LTD.
K070798	ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS	Oct 04, 2007	Substantially Equivalent	COEUR, INC.
K061976	CKIS-004A INJECTOR SYNCHRONIZATION OPTION	Sep 27, 2006	Substantially Equivalent	TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K062168	CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA	Aug 18, 2006	Substantially Equivalent	NEMOTO KYORINDO CO., LTD.
K052744	C2000 AUTOMATED MANIFOLD KIT	Dec 16, 2005	Substantially Equivalent	ACIST MEDICAL SYSTEMS, INC.
K051799	DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS	Nov 02, 2005	Substantially Equivalent	COEUR, INC.
K052633	DUAL SHOT - CONTRAST DELIVERY SYSTEM	Oct 17, 2005	Substantially Equivalent	NEMOTO KYORINDO CO., LTD.
K050456	MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM	Jun 17, 2005	Substantially Equivalent	MEDRAD, INC.
K042784	MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM	Dec 10, 2004	Substantially Equivalent	MEDRAD, INC.
K042744	OPTIV ANTAGE DH POWER INJECTION SYSTEM	Nov 30, 2004	Substantially Equivalent	MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
K040298	ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS	Mar 15, 2004	Substantially Equivalent	ACIST MEDICAL SYSTEMS, INC.
K033881	MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE	Mar 02, 2004	Substantially Equivalent	MEDRAD, INC.
K032920	THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003	Dec 16, 2003	Substantially Equivalent	COEUR MEDICAL
K033247	MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM	Nov 05, 2003	Substantially Equivalent	MEDRAD, INC.
K031483	MEDRAD MANUAL SYRINGE LOADER	Aug 01, 2003	Substantially Equivalent	MEDRAD, INC.
K031339	OPTIBOLUS	Jul 11, 2003	Substantially Equivalent	MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
K020892	ACIST GENTOO CONTRAST INJECTION SYSTEM	Jan 27, 2003	Substantially Equivalent	ACIST MEDICAL SYSTEMS
K023183	MEDRAD STELLANT CT INJECTOR SYSTEM	Jan 10, 2003	Substantially Equivalent	MEDRAD, INC.
K022116	ELPH INJECTION SYSTEM	Jul 26, 2002	Substantially Equivalent	MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
K020333	ATRION MEDICAL QL FLUID DISPENSING SYRINGE	Apr 25, 2002	Substantially Equivalent	ATRION MEDICAL PRODUCTS, INC.
K013815	MEDRAD QWIK-FIT SYRINGE	Dec 13, 2001	Substantially Equivalent	MEDRAD, INC.
K012950	MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM	Oct 04, 2001	Substantially Equivalent	MEDRAD, INC.
K011811	MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE	Aug 22, 2001	Substantially Equivalent	MERIT MEDICAL SYSTEMS, INC.
K011991	MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR	Aug 21, 2001	Substantially Equivalent	MEDRAD, INC.
K010390	ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS	Mar 09, 2001	Substantially Equivalent	ACIST MEDICAL SYSTEMS, INC.
K001663	FRONT-LOAD POLYPROPYLENE SYRINGE	Nov 16, 2000	Substantially Equivalent	MEDRAD, INC.
K991103	MODIFICATION TO ACIST CL 100H	May 31, 2000	Substantially Equivalent	ACIST MEDICAL SYSTEMS
K984231	ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B	May 31, 2000	Substantially Equivalent	INVASATEC
K000013	ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000	Mar 28, 2000	Substantially Equivalent	ACIST MEDICAL SYSTEMS
K983826	3S INJECTOR-CT CONTRAST DELIVERY SYSTEM	Mar 23, 2000	Substantially Equivalent	UNIMACHS CORP.
K993774	ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH	Dec 07, 1999	Substantially Equivalent	ACIST MEDICAL SYSTEMS
K984088	OPTISTAR MR INJECTOR SYSTEM	Dec 06, 1999	Substantially Equivalent	MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
K993728	MEDRAD ENVISION CT INJECTOR SYSTEM	Nov 26, 1999	Substantially Equivalent	MEDRAD, INC.
K991557	MEDRAD VISTRON CT INJECTOR SYSTEM	Jul 21, 1999	Substantially Equivalent	MEDRAD, INC.
K984418	UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET	Mar 11, 1999	Substantially Equivalent	MEDRAD, INC.
K982814	MEDRAD VISTRON CT INJECTOR SYSTEM	Oct 09, 1998	Substantially Equivalent	MEDRAD, INC.
K973334	OZ POWER SYRINGE	Apr 03, 1998	Substantially Equivalent	CARDIOVASCULAR INNOVATIONS
K963982	ACIST ANGIOGRAPHIC INJECTOR	Dec 05, 1997	Substantially Equivalent	INVASATEC
K973230	MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)	Nov 25, 1997	Substantially Equivalent	MERIT MEDICAL SYSTEMS, INC.
K971712	COEUR 130 ML ANGIOGRAPHIC SYRINGE	Oct 08, 1997	Substantially Equivalent	COEUR LABORATORIES, INC.
K963071	ANGIOMAT ILLUMENA	Sep 23, 1997	Substantially Equivalent	MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
K964642	MEDRAD DISPOSABLE SYRINGES	Apr 29, 1997	Substantially Equivalent	MEDRAD, INC.
K962141	VOLUME CONTROL SYRINGE MODEL VCD-SYR-10	Mar 19, 1997	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K955685	RNS STERILE, DISPOSABLE CT BIOPSY TRAY	Oct 04, 1996	Substantially Equivalent	CONTOUR FABRICATORS OF FLORIDA, INC.
K960674	CONTRAST INJECTION LINES	Sep 19, 1996	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K960965	FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211	Sep 12, 1996	Substantially Equivalent	COEUR LABORATORIES, INC.
K960430	CONTROL SYRINGE	Aug 06, 1996	Substantially Equivalent	SCIENTIFIC DEVICE MANUFACTURER LLC.
K955684	RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY	May 02, 1996	Unknown	CONTOUR FABRICATORS OF FLORIDA, INC.
K955381	B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT	Feb 21, 1996	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K935668	MEDRAD SPECTRIS MR INJECTOR	Sep 25, 1995	Substantially Equivalent	MEDRAD, INC.
K951802	SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT	Jul 21, 1995	Substantially Equivalent	SCIMED LIFE SYSTEMS, INC.
K934086	MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGE	Jun 15, 1995	Substantially Equivalent	MEDRAD, INC.
K942381	LOW PRESSURE INJECTION TUBING, COILED LINE, EXTENSION TUBING	Mar 17, 1995	Substantially Equivalent	APOGEE, INC.
K944875	ANGIOMAT 3000, 6000, CT INJECTOR	Jan 04, 1995	Substantially Equivalent	LIEVEL-FLARSHEIM CO.
K933846	ANGIOGRAPHY SYRINGE KITS	Dec 13, 1994	Substantially Equivalent	ANGIODYNAMICS, DIV. E-Z-EM, INC.
K933908	MEDRAD CT CUSTOM CONVENIENCE KIT	Feb 25, 1994	Substantially Equivalent	MEDRAD, INC.
K932083	XDCS-100	Dec 16, 1993	Substantially Equivalent	MICROWAVE MEDICAL SYSTEMS, INC.
K923117	CAVERNOSOMETRY MODULE FOR MENUET	Feb 22, 1993	Substantially Equivalent	DANTEC MEDICAL, INC.
K924116	MEDRAD MCT, MCT PLUS INJECTOR/MEDRAD FRONT LOAD	Jan 21, 1993	Substantially Equivalent	MEDRAD, INC.
K913624	MEDRAD MCT-PLUS INJECTOR	Jul 30, 1992	Substantially Equivalent	MEDRAD, INC.
K920135	MEDROYAL ANGIOGRAPHIC CONTROL SYRINGE	Jul 24, 1992	Substantially Equivalent	MEDROYAL, INC.
K912944	CT 8000 DIGITAL INJECTION SYSTEM	Feb 04, 1992	Substantially Equivalent	MALLINCKRODT GROUP, INC.
K910594	TRAC-WRIGHT SYSTEM, MODEL TW2	Sep 23, 1991	Substantially Equivalent	DOW CORNING WRIGHT
K905819	MEDRAD VARIBLE INFUSION INJECTOR	Sep 16, 1991	Substantially Equivalent	MEDRAD, INC.
K911166	DIAGNOSTIC ULTRASOUND/URO-GYN UD 511	Aug 15, 1991	Substantially Equivalent	DIAGNOSTIC ULTRASOUND CORP.
K911549	INJECTOR FILL TUBE	Jul 18, 1991	Substantially Equivalent	THE R GROUP
K910873	BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP	May 29, 1991	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K904994	CLOSED SYSTEM FLUSH SET	Jan 15, 1991	Substantially Equivalent	ARGON MEDICAL CORP.
K902377	ANGEFLATOR(TM)	Dec 13, 1990	Substantially Equivalent	ANGEION CORP.
K904212	HIGH-PRESSURE CONNECTOR TUBE	Dec 03, 1990	Substantially Equivalent	MALLINCKRODT MEDICAL
K902475	CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS	Dec 03, 1990	Substantially Equivalent	CARDIO-PAK
K903494	MAINTENACE FLOW - ACCESORY DEVICE FOR CAVROPUMP	Oct 17, 1990	Substantially Equivalent	LIFE-TECH INTL., INC.
K903495	LIQUID DETECTOR	Oct 05, 1990	Substantially Equivalent	LIFE-TECH INTL., INC.
K903390	MEDRAD MARK V-PLUS INJECTOR	Sep 26, 1990	Substantially Equivalent	MEDRAD, INC.
K902221	MODIFIED ANGIOGRAPHIC INJECTOR AND SYRINGE	Aug 08, 1990	Substantially Equivalent	MALLINCKRODT GROUP, INC.
K901382	ISOFLO(TM) HIGH PRESSURE INJECTION LINES	Jul 19, 1990	Substantially Equivalent	HEALTHDYNE CARDIOVASCULAR, INC.
K900034	ANGIO-MAX	May 22, 1990	Substantially Equivalent	ACCUMED SYSTEMS, INC.
K896415	USCI PRESTO DISPOSABLE INFLATION DEVICE	Jan 19, 1990	Substantially Equivalent	C.R. BARD, INC.
K895318	B-D ANGIOGRAPHIC CONTROL SYRINGE	Jan 19, 1990	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K890292	PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE	Jun 22, 1989	Substantially Equivalent	COEUR LABORATORIES, INC.
K890208	HIGH PRESSURE CONNECTING SETS	May 19, 1989	Substantially Equivalent	E-Z-EM, INC.
K884913	MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)	Apr 18, 1989	Substantially Equivalent	MERIT MEDICAL SYSTEMS, INC.
K890898	MODEL 611101 CONTRAST INJECTION DEVICE	Apr 12, 1989	Substantially Equivalent	MEDTRONIC VERSAFLEX, INC.
K883769	EXCEL INFLATE-AID	Dec 01, 1988	Substantially Equivalent	MEDICAL PROFILES, INC.
K883452	ACS INDEFLATOR P/T 20	Oct 14, 1988	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K882329	L-F COILED EXTENSION TUBING	Sep 02, 1988	Substantially Equivalent	MALLINCKRODT GROUP, INC.
K881521	MODIFIED SERVO SYRINGE	May 31, 1988	Substantially Equivalent	ENGINEERING, INC.
K880877	CONTRAST INJECTION DEVICE	May 31, 1988	Substantially Equivalent	MED-WEST, INC.
K880987	INJECTOR HANDLE WITH SYRINGE	May 13, 1988	Substantially Equivalent	APPLIED VASCULAR DEVICES, INC.
K880493	MEDRAD MICROPROCESSOR CT INJECTION SYSTEM	Apr 28, 1988	Substantially Equivalent	MEDRAD, INC.
K880310	ANGIO DRAPE PACK ACP-010FM	Apr 22, 1988	Substantially Equivalent	ARROW INTL., INC.
K875324	MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES	Mar 25, 1988	Substantially Equivalent	SCHNEIDER-SHILLEY (USA)
K873410	DISPOSABLE ANGIOGRAPHIC, CONTROL SYRINGE	Mar 25, 1988	Substantially Equivalent	BLOOD GAS SUPPLY CO.
K875196	DISPOSABLE CORONARY CONTROL SYRINGE 12CC	Feb 11, 1988	Substantially Equivalent	MERIT MEDICAL SYSTEMS, INC.
K873955	NAMIC ANGIOGRAPHIC SYRINGE	Feb 05, 1988	Substantially Equivalent	NORTH AMERICAN INSTRUMENT CORP.
K873173	MEDRAD MRI INJECTION SYSTEM	Feb 05, 1988	Substantially Equivalent	MEDRAD, INC.
K873597	TUBING, POLYETHYLENE	Nov 12, 1987	Substantially Equivalent	COEUR LABORATORIES, INC.
K872981	ACS INDEFLATOR PLUS (MODIFICATION #2)	Oct 20, 1987	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K873687	ANGIOMAT CT INJECTOR	Oct 09, 1987	Substantially Equivalent	MALLINCKRODT GROUP, INC.
K872472	SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE	Sep 14, 1987	Substantially Equivalent	ANGIOMEDICS, INC.
K871129	CAVROPUMP	Aug 28, 1987	Substantially Equivalent	LIFE-TECH INTL., INC.
K863596	CHIN-FOGARTY INFLATION DEVICE	Nov 20, 1986	Substantially Equivalent	AMERICAN EDWARDS LABORATORIES
K863537	CORDIS REUSABLE INFLATION DEVICE FOR ANGIOPLASTY	Oct 31, 1986	Substantially Equivalent	CORDIS CORP.
K863037	USCI (R) DISPOSABLE INFLATION DEVICE	Sep 23, 1986	Substantially Equivalent	C.R. BARD, INC.
K862547	MECHANICAL INFLATION DEVICE	Sep 03, 1986	Substantially Equivalent	AMERICAN EDWARDS LABORATORIES
K860204	ANGIOMAT 6000	May 02, 1986	Substantially Equivalent	MALLINCKRODT GROUP, INC.
K860842	ANGIOJECT	Apr 23, 1986	Substantially Equivalent	TARGET THERAPEUTICS
K850861	ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE	Feb 18, 1986	Substantially Equivalent	MEDICAL COMPONENTS, INC.
K854310	ACS INDEFLATOR (MODIFICATION)	Dec 04, 1985	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K841092	HIGH PRESSURE FLEX. CONNECTING TUBING	Jul 24, 1985	Substantially Equivalent	TRONOMED, INC.
K851402	LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE	Jun 10, 1985	Substantially Equivalent	MEDI-TECH, INC.
K844045	ADVANCED CARDIOVASCULAR SYSTEMS ANGIOJECT	Nov 13, 1984	Substantially Equivalent	ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K841493	MODEL 1000 APC-ANGIOPLASTY PRESSURE	Jun 11, 1984	Substantially Equivalent	E.A. FISCHIONE INSTRUMENT MFG.
K840281	ANGIOGRAPHIC DRAPE PACKS	Apr 17, 1984	Substantially Equivalent	MEDRAD, INC.
K833645	CONTRAST MEDIA INJECT. SET CMS	Apr 17, 1984	Substantially Equivalent	GISH BIOMEDICAL, INC.
K834107	ANGIOPLASTY INFLATION DEVICE & CARTR	Jan 13, 1984	Substantially Equivalent	CORDIS CORP.
K833138	DIGITAL INJECTOR SYS	Nov 14, 1983	Substantially Equivalent	SYBRON CORP.
K830754	BLOOD PRESSURE MONITORING KITS,WALRUS	Aug 12, 1983	Substantially Equivalent	MEDICAL PARAMETERS, INC.
K830609	INFLATION DEVICE	Mar 24, 1983	Substantially Equivalent	INTERVENTIONAL MEDICAL, INC.
K823920	COEURLOCK STERILE DISPOS. ANGIOGRAPHIC	Feb 18, 1983	Substantially Equivalent	COEUR LABORATORIES, INC.
K823340	CLEAR VINYL MONITORING CONNECTOR	Dec 30, 1982	Substantially Equivalent	VERTEX MEDICAL CORP.
K823256	ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE	Dec 30, 1982	Substantially Equivalent	VERTEX MEDICAL CORP.
K823254	REUSABLE METAL STOPCOCK	Dec 30, 1982	Substantially Equivalent	VERTEX MEDICAL CORP.
K823253	VERTEX MONITORING CATHETER	Dec 30, 1982	Substantially Equivalent	VERTEX MEDICAL CORP.
K823238	INJECTION FILL TUBE	Dec 30, 1982	Substantially Equivalent	VETREX MEDICAL CORP.
K823192	TUOHY-BORST ADAPTER W/SIDE ARM	Dec 30, 1982	Substantially Equivalent	VERTEX MEDICAL CORP.
K823191	DISPOSABLE PLASTIC STOPCOCK	Dec 30, 1982	Substantially Equivalent	VERTEX MEDICAL CORP.
K823190	BACKSTOP VALVE W/SIDE ARM	Dec 30, 1982	Substantially Equivalent	VERTEX MEDICAL CORP.
K823356	READY-BOX BODY-TEMP MEDIA WARMER MALLIN-	Dec 03, 1982	Substantially Equivalent	FORMA SCIENTIFIC, INC.
K822536	MARK V	Sep 28, 1982	Substantially Equivalent	MEDRAD, INC.
K821401	MALLINCKRODT DIAG. MEDIA WARMER	Jun 17, 1982	Substantially Equivalent	FORMA SCIENTIFIC, INC.
K800823	QUICK FILL	Apr 29, 1980	Substantially Equivalent	MEDRAD, INC.
K800613	ANGIOPLASTY INJECTOR	Apr 08, 1980	Substantially Equivalent	MEDRAD, INC.
K791793	USCI PRESSURE GAUGE	Dec 11, 1979	Substantially Equivalent	C.R. BARD, INC.
K791782	USCI BALLOON DILATATION INFLATION DEV.	Dec 11, 1979	Substantially Equivalent	C.R. BARD, INC.
K790835	DYNAJECT	Jun 22, 1979	Substantially Equivalent	ATOMIC PRODUCTS CORP.
K781334	DISPOSABLE SYRINGE FILL TUBE	Aug 17, 1978	Substantially Equivalent	MALLINCKRODT GROUP, INC.

FEI Numbers

This FDA classification entry is associated with 120 FEI numbers. Click on an entry to view related FDA registrations.

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