18 Fr. Rmi Arterial Perfusion Cannula II, 20 Fr. Rmi Arterial Perfusion Cannula II
FDA 510(k) K073559 · Edwards Lifesciences Research Medical
510(k) numberK073559
Submission
- Device name
- 18 Fr. Rmi Arterial Perfusion Cannula II, 20 Fr. Rmi Arterial Perfusion Cannula II
- Applicant
- Edwards Lifesciences Research Medical
Midvale, UT, US - Received
- December 19, 2007
- Decision date
- January 31, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQR – Cannula, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1300
- Specialty
- Cardiovascular
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| 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 |
More from Argon Medical Corp.
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|---|---|---|
| K062429 | Modification to Embol-X Intra-Aortic Filter: X-Small, Small, Medium, Large, X-Large with…DTM · Traditional | 09/27/2006SE |
| K990396 | T-AnastafloDWF · Traditional | 10/01/1999SE |
| K991170 | Retrograde Cardioplegia Cannula with Duraflo Treatment, Model DII-RC-014DWF · Traditional | 07/02/1999SE |
| K983791 | Peripheral Retrograde Cardiaplegia CannulaDWF · Traditional | 06/11/1999SE |
| K974259 | Venous Flex II Peripheral and Intra-Operative Access Venous Return CannulaeDWF · Traditional | 12/01/1998SE |
Questions and answers
When was 18 Fr. Rmi Arterial Perfusion Cannula II, 20 Fr. Rmi Arterial Perfusion Cannula II cleared by the FDA?
18 Fr. Rmi Arterial Perfusion Cannula II, 20 Fr. Rmi Arterial Perfusion Cannula II (K073559) received a 510(k) decision of Substantially Equivalent on January 31, 2008, 43 days after the submission was received.
What is the product code of K073559?
The FDA product code is DQR – Cannula, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1300.