The following data is part of a premarket notification filed by Menlo Care, Inc. with the FDA for Versacath(tm0 Mainline(tm) With Introduction Tray.
| Device ID | K910564 |
| 510k Number | K910564 |
| Device Name: | VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | MENLO CARE, INC. 1350 WILLOW RD. Menlo Park, CA 94025 -1516 |
| Contact | Jock M Walker |
| Correspondent | Jock M Walker MENLO CARE, INC. 1350 WILLOW RD. Menlo Park, CA 94025 -1516 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-08 |
| Decision Date | 1991-05-06 |