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 |