The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Intro-flex Sheath Introducer W/amc Thromboshield.
| Device ID | K885179 |
| 510k Number | K885179 |
| Device Name: | INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD |
| Classification | Introducer, Catheter |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Contact | Corrine M Taflinger |
| Correspondent | Corrine M Taflinger BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-14 |
| Decision Date | 1989-08-09 |