The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Baxter Accuport(tm) Central Venous Catheter.
Device ID | K874618 |
510k Number | K874618 |
Device Name: | BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER |
Classification | Cannula, Catheter |
Applicant | BENTLEY LABORATORIES, INC. 17502 ARMSTRONG AVE. P.O. BOX 19522 Irvine, CA 92713 -9522 |
Contact | Merritt Girgis |
Correspondent | Merritt Girgis BENTLEY LABORATORIES, INC. 17502 ARMSTRONG AVE. P.O. BOX 19522 Irvine, CA 92713 -9522 |
Product Code | DQR |
CFR Regulation Number | 870.1300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-09 |
Decision Date | 1988-01-19 |