Product Code: KRI FDA class 1 21 CFR 870.4200

Accessory Equipment, Cardiopulmonary Bypass

Cardiovascular

This device comprises accessory equipment for cardiopulmonary bypass, including ancillary components that support the extracorporeal circulation circuit used during open heart surgery to maintain blood flow and oxygenation while the heart is stopped. It is classified as FDA Class 1, the lowest risk level, subject to general controls only. The product code is KRI, regulated under 21 CFR 870.4200 within the Cardiovascular specialty. No special flags apply.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: KRI
Device Class: FDA class 1
Regulation Number: 870.4200
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 4

Device Characteristics

✗

GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 42 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K020365	3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE	May 03, 2002	Substantially Equivalent	3t Medical Systems, LLC
K992635	INTERFACE MODULE IDDD	Dec 20, 1999	Substantially Equivalent	Stoeckert Instrumente
K990512	STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS	Nov 23, 1999	Substantially Equivalent	Stoeckert Instrumente
K934782	AMMEX TUBING ORGANIZER	Nov 18, 1993	Substantially Equivalent	Ammex Cardiopulmonary Corp.
K926233	CARDIO2 CYCLE	Jun 04, 1993	Substantially Equivalent	Ergometrix, Inc.
K922404	TUBE GRIP	Nov 23, 1992	Substantially Equivalent	Georgia Medical Products, Inc.
K892856	NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS	Nov 08, 1989	Substantially Equivalent	Acacia Laboratories, Inc.
K884893	CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25	Jan 30, 1989	Substantially Equivalent	American Omni Medical, Inc.
K884640	CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700	Jan 24, 1989	Substantially Equivalent	American Omni Medical, Inc.
K874605	HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR	Feb 02, 1988	Substantially Equivalent	Mallinckrodt Critical Care
K874925	CPE 2000 CARDIO PULMONARY ERGOMETER	Jan 19, 1988	Substantially Equivalent	Medical Graphics Corp.
K864890	STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP	Feb 19, 1987	Substantially Equivalent	Shiley, Inc.
K862510	STOCKERT-SHILEY CAPS 4 CHANNEL TEMP. MONITOR 1	Jul 17, 1986	Substantially Equivalent	Shiley, Inc.
K862549	ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE	Jul 15, 1986	Substantially Equivalent	American Bentley
K860298	STABLELINE	Apr 02, 1986	Substantially Equivalent	Cardio Metrics, Inc.
K860672	ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HL	Mar 03, 1986	Substantially Equivalent	American Bentley
K854113	CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH	Jan 08, 1986	Substantially Equivalent	American Bentley
K852455	GAMBRO DIGITAL TELETHERMOMETER TTH 10-200	Sep 16, 1985	Substantially Equivalent	Gambro, Inc.
K851077	CARDIAC COOLING JACKET	Jul 11, 1985	Substantially Equivalent	Pat O. Daily
K851289	COBE GAS FILTER	Jun 19, 1985	Substantially Equivalent	Cobe Laboratories, Inc.
K841812	HOLDER FOR BOS-10, 10S 5S	Jun 11, 1984	Substantially Equivalent	American Bentley
K841296	TUBE TENDER	Jun 11, 1984	Substantially Equivalent	The Anspach Effort, Inc.
K841032	HOLDER FOR MODELS AF-10,1025,1040,5	Apr 17, 1984	Substantially Equivalent	American Bentley
K832704	SHILEY GAS FILTER	Sep 29, 1983	Substantially Equivalent	Shiley, Inc.
K832411	GASLINE FILTER #GF-10	Sep 12, 1983	Substantially Equivalent	American Bentley
K830167	HOLDER FOR BOS-2S INFANT BUBBLE OXYGENA-	Mar 11, 1983	Substantially Equivalent	American Bentley
K822097	D645-BACTERIOLOGICAL GAS LINE FILTER	Jul 30, 1982	Substantially Equivalent	Electromedics, Inc.
K820406	TMO INTEGRATED CIRCUIT SYSTEM	Mar 02, 1982	Substantially Equivalent	Travenol Laboratories, S.A.
K813271	TEMPERATURE PROBES	Dec 29, 1981	Substantially Equivalent	Webster Laboratories, Inc.
K811368	CARDIOPLEGIA COOLING & ADMIN. SETS	Jun 09, 1981	Substantially Equivalent	Bentley Laboratories, Inc.
K811348	CARDIOPULMONARY BYPASS ACCESSORY EQUIP.	May 29, 1981	Substantially Equivalent	Bentley Laboratories, Inc.
K810079	SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS	Jan 30, 1981	Substantially Equivalent	3M Health Care, Sarns
K802542	DISPOSABLE CONNECTORS	Jan 16, 1981	Substantially Equivalent	Texas Medical Products, Inc.
K802541	DISPOSABLE PARALLEL Y CONNECTORS	Jan 16, 1981	Substantially Equivalent	Texas Medical Products, Inc.
K802539	DISPOSABLE GAS LINE FILTER	Jan 16, 1981	Substantially Equivalent	Texas Medical Products, Inc.
K802906	WILLIAM HARVEY OXYGENATING GAS FILTER	Dec 16, 1980	Substantially Equivalent	C.R. Bard, Inc.
K792151	OXYGENATOR GAS LINE FILTER	Nov 13, 1979	Substantially Equivalent	Cardio Systems, Inc.
K791829	SHILEY QUICK DISCONNECT ASSEMBLY	Oct 02, 1979	Substantially Equivalent	Shiley, Inc.
K790192	SARNO SINGLE POLE MAST	Feb 08, 1979	Substantially Equivalent	Sames, Inc.
K781861	FILTER, EXTRACORPOREAL BLOOD HOLDER	Nov 15, 1978	Substantially Equivalent	Surgikos, Inc.
K780984	PVC QUICK PRIME LINES	Jul 17, 1978	Substantially Equivalent	Norton Performance Plastics Corp.
K770681	VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR	Apr 26, 1977	Substantially Equivalent	Scimed Life Systems, Inc.