The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Peel-away Introducer Set.
| Device ID | K170020 |
| 510k Number | K170020 |
| Device Name: | Peel-Away Introducer Set |
| Classification | Introducer, Catheter |
| Applicant | Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
| Contact | Colin Jacob |
| Correspondent | Colin Jacob Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-03 |
| Decision Date | 2017-09-28 |
| Summary: | summary |