The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Multi-med Infusion Catheter And Kit Double/triple.
Device ID | K883174 |
510k Number | K883174 |
Device Name: | MULTI-MED INFUSION CATHETER AND KIT DOUBLE/TRIPLE |
Classification | Catheter, Percutaneous |
Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
Contact | Corrine Taflinger |
Correspondent | Corrine Taflinger BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-27 |
Decision Date | 1988-10-14 |