The following data is part of a premarket notification filed by Enpath Medical Incorporated with the FDA for Enpath Safety Introducer.
| Device ID | K041708 |
| 510k Number | K041708 |
| Device Name: | ENPATH SAFETY INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | ENPATH MEDICAL INCORPORATED 15301 HWY. 55 WEST Minneapolis, MN 55447 |
| Contact | Karyl Haskell |
| Correspondent | Karyl Haskell ENPATH MEDICAL INCORPORATED 15301 HWY. 55 WEST Minneapolis, MN 55447 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-23 |
| Decision Date | 2004-11-30 |
| Summary: | summary |