The following data is part of a premarket notification filed by Injectimed, Inc. with the FDA for Safetynet Guidewire Introducer.
| Device ID | K040029 |
| 510k Number | K040029 |
| Device Name: | SAFETYNET GUIDEWIRE INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | INJECTIMED, INC. 6442 MERLIN DRIVE Carlsbad, CA 92009 |
| Contact | George C Brdlik |
| Correspondent | George C Brdlik INJECTIMED, INC. 6442 MERLIN DRIVE Carlsbad, CA 92009 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-08 |
| Decision Date | 2004-04-05 |
| Summary: | summary |