K193133 is an FDA 510(k) clearance for the Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set. This device is classified as a Tube Tracheostomy And Tube Cuff (Class II - Special Controls, product code JOH).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on December 12, 2019, 30 days after receiving the submission on November 12, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.
| 510(k) Number | K193133 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2019 |
| Decision Date | December 12, 2019 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | JOH — Tube Tracheostomy And Tube Cuff |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5800 |