The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Micropuncture Introducer Set, Micropuncture Introducer Set With Push-plus Design, Micropuncture Introducer Set With Silhouette Transitionless Design, Micropuncture Introducer Set With Silhouette Transitionless Design And Push-plus Design.
| Device ID | K171275 |
| 510k Number | K171275 |
| Device Name: | Micropuncture Introducer Set, Micropuncture Introducer Set With Push-Plus Design, Micropuncture Introducer Set With Silhouette Transitionless Design, Micropuncture Introducer Set With Silhouette Transitionless Design And Push-Plus Design |
| Classification | Introducer, Catheter |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Daniel J. Corbin |
| Correspondent | Daniel J. Corbin Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-01 |
| Decision Date | 2017-12-20 |
| Summary: | summary |