Cannula, Catheter
FDA product code DQR · Class II (moderate risk) · 21 CFR 870.1300 · Cardiovascular
25510(k) clearances
0PMA approvals
9recalls
Manufacturers
- Shiley, Inc. 3
- Research Medical, Inc. 2
- Medsurg Industries, Inc. 2
- Harbor Medical Devices, Inc. 2
- Integra LifeSciences Corp. 1
- Sherwood Medical Industries 1
- Edwards Lifesciences Research Medical, Inc. 1
- Angiodynamics, Inc. 1
- Cardiacassist, Inc. 1
- Datascope Corp. 1
- Daig Corp. 1
- Argon Medical Corp. 1
- Medical Repackers Co. 1
- Gresco International, Inc. 1
- Bentley Laboratories, Inc. 1
- Toray Industries (America), Inc. 1
- Luther Medical Products, Inc. 1
- Exco, Inc. 1
- Electro-Catheter Corp. 1
- Dravon Medical, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K131446 | Integra Jarit Heparin Cannulas, Injectors, and NeedlesDQR · Traditional | Integra LifeSciences Corporation | 10/28/2013SE |
| K073559 | 18 Fr. Rmi Arterial Perfusion Cannula II, 20 Fr. Rmi Arterial Perfusion Cannula IIDQR · Special | Edwards Lifesciences Research Medical | 01/31/2008SE |
| K051655 | Angiodynamics, Inc., Micro Access KitsDQR · Traditional | AngioDynamics, Inc. | 09/12/2005SE |
| K030398 | Cardiacassist Transseptal Cannula Set, Model 5132-6221DQR · Traditional | Cardiacassist, Inc. | 05/23/2003SE |
| K960098 | Rmi Internal Mammary Artery CannulaDQR · Traditional | Research Medical, Inc. | 03/26/1996SE |
| K902674 | Datascope Arterial Cannula W/Access PortDQR · Traditional | Datascope Corp. | 01/16/1991SE |
| K894784 | Modified Shiley Femoral Venous CannulaDQR · Traditional | Shiley, Inc. | 03/28/1990SE |
| K894243 | Rmi Arterial Perfusion CannulaDQR · Traditional | Research Medical, Inc. | 09/19/1989SE |
| K884628 | Harborin Central Venous CatheterDQR · Traditional | Harbor Medical Devices, Inc. | 05/15/1989SE |
| K884478 | Daig Collapsible Sterile SleeveDQR · Traditional | Daig Corp. | 02/22/1989SE |
| K884375 | Translumbar Aortography Needle CatheterDQR · Traditional | Argon Medical Corp. | 01/11/1989SE |
| K882977 | ASK-300DQR · Traditional | Medical Repackers Co. | 01/05/1989SE |
| K881884 | Harbor Central Venous CatheterDQR · Traditional | Harbor Medical Devices, Inc. | 07/28/1988SE |
| K880771 | Medsurg 7 Fr. Dual Lumen Central Vein Cath SystemDQR · Traditional | Medsurg Industries, Inc. | 05/03/1988SE |
| K880776 | 7 Fr. Triple Lumen Central Vein Catheteri. SystemDQR · Traditional | Medsurg Industries, Inc. | 05/02/1988SE |
| K873012 | Infant CannulaDQR · Traditional | Gresco International, Inc. | 05/02/1988SE |
| K874618 | Baxter Accuport(Tm) Central Venous CatheterDQR · Traditional | Bentley Laboratories, Inc. | 01/19/1988SE |
| K872983 | Toray Anthron Angiographic CathetersDQR · Traditional | Toray Industries (America), Inc. | 11/20/1987SE |
| K870826 | Additional Letter Designation for Aortic Arch Can.DQR · Traditional | Shiley, Inc. | 03/23/1987SE |
| K870825 | New Model Styles for Aortic Arch CannulaDQR · Traditional | Shiley, Inc. | 03/23/1987SE |
| K820102 | Subclavian Jugular Catheter SetDQR · Traditional | Luther Medical Products, Inc. | 01/29/1982SE |
| K813144 | Intraflon, Intraflux, IntravalveDQR · Traditional | Exco, Inc. | 11/27/1981SE |
| K803002 | Elecath Fluid-Drain AssemblyDQR · Traditional | Electro-Catheter Corp. | 12/22/1980SE |
| K780079 | Cannula, Artery, RenalDQR · Traditional | Dravon Medical, Inc. | 02/13/1978SE |
| K770512 | Cannula, Intravenous, RDQR · Traditional | Sherwood Medical Industries | 03/30/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2085-2025 Class I | Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number:…due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula… | Edwards Lifesciences, LLC | 05/14/2025Open, Classified |
| Z-2084-2025 Class I | Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number:…due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula… | Edwards Lifesciences, LLC | 05/14/2025Open, Classified |
| Z-2083-2025 Class I | Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number:…due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula… | Edwards Lifesciences, LLC | 05/14/2025Open, Classified |
| Z-2082-2025 Class I | Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number:…due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula… | Edwards Lifesciences, LLC | 05/14/2025Open, Classified |
| Z-2081-2025 Class I | Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula…due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula… | Edwards Lifesciences, LLC | 05/14/2025Open, Classified |
| Z-2080-2025 Class I | Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula…due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula… | Edwards Lifesciences, LLC | 05/14/2025Open, Classified |
| Z-0418-2021 Class II | Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction…5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component | Angiodynamics, Inc. | 10/14/2020Terminated |
| Z-3034-2018 Class II | Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization… | SPS Sterilization, Inc | 03/07/2018Terminated |
| Z-1405-2013 Class II | AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F…AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because… | Angiodynamics, Inc. | 04/30/2013Terminated |