The following data is part of a premarket notification filed by Vitaid, Ltd. with the FDA for Selfcath.
| Device ID | K901738 |
| 510k Number | K901738 |
| Device Name: | SELFCATH |
| Classification | Catheter, Urological |
| Applicant | VITAID, LTD. 269 PORTAGE RD. Lewiston, NY 14092 |
| Contact | William G Stewart |
| Correspondent | William G Stewart VITAID, LTD. 269 PORTAGE RD. Lewiston, NY 14092 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-17 |
| Decision Date | 1990-06-27 |