The following data is part of a premarket notification filed by Enpath Medical, Inc. with the FDA for Stiffer Coaxial Micro-introducer Kit.
| Device ID | K071574 |
| 510k Number | K071574 |
| Device Name: | STIFFER COAXIAL MICRO-INTRODUCER KIT |
| 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 | 2007-06-08 |
| Decision Date | 2007-07-05 |
| Summary: | summary |