S-610 Shunt Adaptor Set
FDA 510(k) K811851 · Dravon Medical, Inc.
510(k) numberK811851
Submission
- Device name
- S-610 Shunt Adaptor Set
- Applicant
- Dravon Medical, Inc.
Mchenry, IL, US - Received
- July 1, 1981
- Decision date
- August 31, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNR – Adapter, A-V Shunt Or Fistula
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
More from Dravon Medical, Inc.
| 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 |
| 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 |
| K781755 | Dap-PakKDJ · Traditional | 02/15/1979SE |
Questions and answers
When was S-610 Shunt Adaptor Set cleared by the FDA?
S-610 Shunt Adaptor Set (K811851) received a 510(k) decision of Substantially Equivalent on August 31, 1981, 61 days after the submission was received.
What is the product code of K811851?
The FDA product code is KNR – Adapter, A-V Shunt Or Fistula, a Class II (moderate risk) device regulated under 21 CFR 876.5540.