The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Ciaglia Percutaneous Tracheostomy Introducer Set/tray, Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set/tray.
| Device ID | K133597 |
| 510k Number | K133597 |
| Device Name: | CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | COOK, INC. 750 DANIELS WAY Bloomington, IN 47404 |
| Contact | Sean Spence |
| Correspondent | Sean Spence COOK, INC. 750 DANIELS WAY Bloomington, IN 47404 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-22 |
| Decision Date | 2014-04-18 |
| Summary: | summary |