The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Performer Guiding Sheath.
| Device ID | K171988 |
| 510k Number | K171988 |
| Device Name: | Performer Guiding Sheath |
| Classification | Introducer, Catheter |
| Applicant | Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 |
| Contact | Reuben G. Lidster |
| Correspondent | Reuben G. Lidster 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 | 2017-07-03 |
| Decision Date | 2018-03-30 |
| Summary: | summary |