The following data is part of a premarket notification filed by Enpath Medical Incorporated with the FDA for Enpath Deflectable Catheter.
| Device ID | K043489 |
| 510k Number | K043489 |
| Device Name: | ENPATH DEFLECTABLE CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | ENPATH MEDICAL INCORPORATED 15301 HWY. 55 WEST Minneapolis, MN 55447 |
| Contact | Karyl D Haskell |
| Correspondent | Karyl D Haskell ENPATH MEDICAL INCORPORATED 15301 HWY. 55 WEST Minneapolis, MN 55447 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-17 |
| Decision Date | 2005-05-19 |
| Summary: | summary |