The following data is part of a premarket notification filed by Enpath Medical, Inc. with the FDA for Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-xxx.
| Device ID | K063182 |
| 510k Number | K063182 |
| Device Name: | ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX |
| Classification | Introducer, Catheter |
| 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-19 |
| Decision Date | 2006-12-21 |
| Summary: | summary |