The following data is part of a premarket notification filed by Enpath Medical, Inc. with the FDA for Viapeel Peelable Introducer.
| Device ID | K072248 |
| 510k Number | K072248 |
| Device Name: | VIAPEEL PEELABLE INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | ENPATH MEDICAL, INC. 2300 BERKSHIRE LANE NORTH Minneapolis, MN 55441 |
| Contact | Patrice Stromberg |
| Correspondent | Patrice Stromberg ENPATH MEDICAL, INC. 2300 BERKSHIRE LANE NORTH Minneapolis, MN 55441 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-13 |
| Decision Date | 2007-11-09 |
| Summary: | summary |