Product Code: DQR FDA class 2 21 CFR 870.1300

Cannula, Catheter

Cardiovascular

The Catheter Cannula is a cardiovascular access device used to introduce catheters or other instruments into a blood vessel, facilitating vascular access for diagnostic or therapeutic procedures. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DQR and it is regulated under 21 CFR 870.1300 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DQR
Device Class: FDA class 2
Regulation Number: 870.1300
Medical Specialty: Cardiovascular
Review Panel: CV
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 25 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K131446	INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES	Oct 28, 2013	Substantially Equivalent	Integra LifeSciences Corporation
K073559	18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II	Jan 31, 2008	Substantially Equivalent	Edwards Lifesciences Research Medical
K051655	ANGIODYNAMICS, INC., MICRO ACCESS KITS	Sep 12, 2005	Substantially Equivalent	AngioDynamics, Inc.
K030398	CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221	May 23, 2003	Substantially Equivalent	Cardiacassist, Inc.
K960098	RMI INTERNAL MAMMARY ARTERY CANNULA	Mar 26, 1996	Substantially Equivalent	Research Medical, Inc.
K902674	DATASCOPE ARTERIAL CANNULA W/ACCESS PORT	Jan 16, 1991	Substantially Equivalent	Datascope Corp.
K894784	MODIFIED SHILEY FEMORAL VENOUS CANNULA	Mar 28, 1990	Substantially Equivalent	Shiley, Inc.
K894243	RMI ARTERIAL PERFUSION CANNULA	Sep 19, 1989	Substantially Equivalent	Research Medical, Inc.
K884628	HARBORIN CENTRAL VENOUS CATHETER	May 15, 1989	Substantially Equivalent	Harbor Medical Devices, Inc.
K884478	DAIG COLLAPSIBLE STERILE SLEEVE	Feb 22, 1989	Substantially Equivalent	Daig Corp.
K884375	TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER	Jan 11, 1989	Substantially Equivalent	Argon Medical Corp.
K882977	ASK-300	Jan 05, 1989	Substantially Equivalent	Medical Repackers Co.
K881884	HARBOR CENTRAL VENOUS CATHETER	Jul 28, 1988	Substantially Equivalent	Harbor Medical Devices, Inc.
K880771	MEDSURG 7 FR. DUAL LUMEN CENTRAL VEIN CATH SYSTEM	May 03, 1988	Substantially Equivalent	Medsurg Industries, Inc.
K880776	7 FR. TRIPLE LUMEN CENTRAL VEIN CATHETERI. SYSTEM	May 02, 1988	Substantially Equivalent	Medsurg Industries, Inc.
K873012	INFANT CANNULA	May 02, 1988	Substantially Equivalent	Gresco International, Inc.
K874618	BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER	Jan 19, 1988	Substantially Equivalent	Bentley Laboratories, Inc.
K872983	TORAY ANTHRON ANGIOGRAPHIC CATHETERS	Nov 20, 1987	Substantially Equivalent	Toray Industries (America), Inc.
K870826	ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN.	Mar 23, 1987	Substantially Equivalent	Shiley, Inc.
K870825	NEW MODEL STYLES FOR AORTIC ARCH CANNULA	Mar 23, 1987	Substantially Equivalent	Shiley, Inc.
K820102	SUBCLAVIAN JUGULAR CATHETER SET	Jan 29, 1982	Substantially Equivalent	Luther Medical Products, Inc.
K813144	INTRAFLON, INTRAFLUX, INTRAVALVE	Nov 27, 1981	Substantially Equivalent	Exco, Inc.
K803002	ELECATH FLUID-DRAIN ASSEMBLY	Dec 22, 1980	Substantially Equivalent	Electro-Catheter Corp.
K780079	CANNULA, ARTERY, RENAL	Feb 13, 1978	Substantially Equivalent	Dravon Medical, Inc.
K770512	CANNULA, INTRAVENOUS, R	Mar 30, 1977	Substantially Equivalent	Sherwood Medical Industries