DQR · Cannula, Catheter
Cardiovascular · 21 CFR 870.1300 · Class 2
Overview
| Product Code | DQR |
|---|---|
| Device Name | Cannula, Catheter |
| Regulation | 21 CFR 870.1300 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A catheter cannula is a hollow tube which is inserted into a vessel or cavity; this device provides a rigid or semirigid structure which can be connected to a tube or connector.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 25)
Showing 20 most recent of 25 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K131446 | INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES | Integra LifeSciences Corporation | Oct 28, 2013 | SESE |
| K073559 | 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II | Edwards Lifesciences Research Medical | Jan 31, 2008 | SESE |
| K051655 | ANGIODYNAMICS, INC., MICRO ACCESS KITS | AngioDynamics, Inc. | Sep 12, 2005 | SESE |
| K030398 | CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 | Cardiacassist, Inc. | May 23, 2003 | SESE |
| K960098 | RMI INTERNAL MAMMARY ARTERY CANNULA | Research Medical, Inc. | Mar 26, 1996 | SESE |
| K902674 | DATASCOPE ARTERIAL CANNULA W/ACCESS PORT | Datascope Corp. | Jan 16, 1991 | SESE |
| K894784 | MODIFIED SHILEY FEMORAL VENOUS CANNULA | Shiley, Inc. | Mar 28, 1990 | SESE |
| K894243 | RMI ARTERIAL PERFUSION CANNULA | Research Medical, Inc. | Sep 19, 1989 | SESE |
| K884628 | HARBORIN CENTRAL VENOUS CATHETER | Harbor Medical Devices, Inc. | May 15, 1989 | SESE |
| K884478 | DAIG COLLAPSIBLE STERILE SLEEVE | Daig Corp. | Feb 22, 1989 | SESE |
| K884375 | TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER | Argon Medical Corp. | Jan 11, 1989 | SESE |
| K882977 | ASK-300 | Medical Repackers Co. | Jan 5, 1989 | SESE |
| K881884 | HARBOR CENTRAL VENOUS CATHETER | Harbor Medical Devices, Inc. | Jul 28, 1988 | SESE |
| K880771 | MEDSURG 7 FR. DUAL LUMEN CENTRAL VEIN CATH SYSTEM | Medsurg Industries, Inc. | May 3, 1988 | SESE |
| K880776 | 7 FR. TRIPLE LUMEN CENTRAL VEIN CATHETERI. SYSTEM | Medsurg Industries, Inc. | May 2, 1988 | SESE |
| K873012 | INFANT CANNULA | Gresco International, Inc. | May 2, 1988 | SESE |
| K874618 | BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER | Bentley Laboratories, Inc. | Jan 19, 1988 | SESE |
| K872983 | TORAY ANTHRON ANGIOGRAPHIC CATHETERS | Toray Industries (America), Inc. | Nov 20, 1987 | SESE |
| K870826 | ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN. | Shiley, Inc. | Mar 23, 1987 | SESE |
| K870825 | NEW MODEL STYLES FOR AORTIC ARCH CANNULA | Shiley, Inc. | Mar 23, 1987 | SESE |
Top Applicants
- Shiley, Inc. — 3 clearances
- Harbor Medical Devices, Inc. — 2 clearances
- Medsurg Industries, Inc. — 2 clearances
- Research Medical, Inc. — 2 clearances
- AngioDynamics, Inc. — 1 clearance
