The following data is part of a premarket notification filed by Warne Surgical Products, Ltd. with the FDA for Kidney Transplant Catheter.
| Device ID | K840687 |
| 510k Number | K840687 |
| Device Name: | KIDNEY TRANSPLANT CATHETER |
| Classification | System, Perfusion, Kidney |
| Applicant | WARNE SURGICAL PRODUCTS, LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KDN |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-15 |
| Decision Date | 1984-06-07 |