The following data is part of a premarket notification filed by Renal Systems, Inc. with the FDA for Arterio Venous Shunt Cannula & Adaptors.
| Device ID | K822880 |
| 510k Number | K822880 |
| Device Name: | ARTERIO VENOUS SHUNT CANNULA & ADAPTORS |
| Classification | Cannula, A-v Shunt |
| Applicant | RENAL SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FIQ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-21 |
| Decision Date | 1982-10-18 |