The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Percutaneous Introducers.
| Device ID | K903530 |
| 510k Number | K903530 |
| Device Name: | PERCUTANEOUS INTRODUCERS |
| Classification | Introducer, Catheter |
| Applicant | DAVOL, INC. 3385 WEST 1820 Salt Lake City, UT 84104 |
| Contact | Jack Speer |
| Correspondent | Jack Speer DAVOL, INC. 3385 WEST 1820 Salt Lake City, UT 84104 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-06 |
| Decision Date | 1990-10-22 |