The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Shuttle Sl Flexor Tuohy-borst Side-arm Introducer Set.
| Device ID | K142819 |
| 510k Number | K142819 |
| Device Name: | Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set |
| Classification | Introducer, Catheter |
| Applicant | COOK INCORPORATED 750 DANIELS WAY P.O. BOX 489 Bloomington, IN 47402 |
| Contact | Steven Lawrie |
| Correspondent | Steven Lawrie 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 | 2014-09-29 |
| Decision Date | 2015-07-24 |
| Summary: | summary |