The following data is part of a premarket notification filed by Baxter Edwards with the FDA for Baxter Hemostasis Valve Introducers.
Device ID | K981909 |
510k Number | K981909 |
Device Name: | BAXTER HEMOSTASIS VALVE INTRODUCERS |
Classification | Introducer, Catheter |
Applicant | BAXTER EDWARDS 17221 RED HILL AVE. Irvine, CA 92614 -5627 |
Contact | Scott Beggins |
Correspondent | Scott Beggins BAXTER EDWARDS 17221 RED HILL AVE. Irvine, CA 92614 -5627 |
Product Code | DYB |
CFR Regulation Number | 870.1340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-06-01 |
Decision Date | 1998-11-24 |
Summary: | summary |