The following data is part of a premarket notification filed by Innerdyne, Inc. with the FDA for Innerdyne Radially Expanding Vascular Access System (heparin Coated).
| Device ID | K980578 |
| 510k Number | K980578 |
| Device Name: | INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED) |
| Classification | Introducer, Catheter |
| Applicant | INNERDYNE, INC. 5060 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Contact | Rick Gaykowski |
| Correspondent | Rick Gaykowski INNERDYNE, INC. 5060 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-17 |
| Decision Date | 1998-09-11 |
| Summary: | summary |