The following data is part of a premarket notification filed by Enpath Medical, Inc. with the FDA for Enpath Medical Steerable Sheath.
| Device ID | K061119 |
| 510k Number | K061119 |
| Device Name: | ENPATH MEDICAL STEERABLE SHEATH |
| Classification | Catheter, Percutaneous |
| Applicant | ENPATH MEDICAL, INC. 15301 HWY. 55 WEST Minneapolis, MN 55447 |
| Contact | James Jenkins |
| Correspondent | James Jenkins ENPATH MEDICAL, INC. 15301 HWY. 55 WEST Minneapolis, MN 55447 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-21 |
| Decision Date | 2006-05-18 |
| Summary: | summary |