The following data is part of a premarket notification filed by Baxter Edwards with the FDA for Multi-med Multi-lumen Central Venous Catheter.
Device ID | K955839 |
510k Number | K955839 |
Device Name: | MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | BAXTER EDWARDS 17221 RED HILL AVE. Irvine, CA 92614 -5627 |
Contact | Irene Parker |
Correspondent | Irene Parker BAXTER EDWARDS 17221 RED HILL AVE. Irvine, CA 92614 -5627 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-26 |
Decision Date | 1996-03-25 |