Cannula, Artery, Renal
FDA 510(k) K780079 · Dravon Medical, Inc.
510(k) numberK780079
Submission
- Device name
- Cannula, Artery, Renal
- Applicant
- Dravon Medical, Inc.
Mchenry, IL, US - Received
- January 16, 1978
- Decision date
- February 13, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQR – Cannula, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1300
- Specialty
- Cardiovascular
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| 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 |
More from Daig Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K873455 | S3086 Arterial, S3087 Venous Neonatal HemodialysisFJK · Traditional | 09/14/1987SE |
| K860770 | AM-100 I/A AmpacHQC · Traditional | 04/21/1986SE |
| K832739 | Stediflo Infusion SetLDR · Traditional | 12/22/1983SE |
| K831842 | Dravon T ClampKDC · Traditional | 09/26/1983SE |
| K812772 | Peritoneal Dialysis Cycler Set (8UNIT)KDJ · Traditional | 10/19/1981SE |
| K812771 | Peritoneal Dialysis DrainageKDJ · Traditional | 10/19/1981SE |
| K811851 | S-610 Shunt Adaptor SetKNR · Traditional | 08/31/1981SE |
| K800435 | Hemostatic/Tube Occluding ForcepsGEN · Traditional | 03/12/1980SE |
| K782058 | Catheter, Beta-Cap-PeritonealFJS · Traditional | 02/27/1979SE |
| K782057 | Catheter, Radiopaque TenckhoffFJS · Traditional | 02/27/1979SE |
Questions and answers
When was Cannula, Artery, Renal cleared by the FDA?
Cannula, Artery, Renal (K780079) received a 510(k) decision of Substantially Equivalent on February 13, 1978, 28 days after the submission was received.
What is the product code of K780079?
The FDA product code is DQR – Cannula, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1300.