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
FDA 510(k) clearance K193133 · decided 2019-12-12
Clearance details
- K-number
- K193133
- Device name
- 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
- Applicant
- Cook Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2019-11-12
- Decision date
- 2019-12-12
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- JOH
- Device class
- 2
- Regulation number
- 868.5800
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bloomington, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part recall (Z-1779-2026) | Cook Incorporated | 2026-04-06 |
| COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part recall (Z-1780-2026) | Cook Incorporated | 2026-04-06 |
| Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTI recall (Z-1427-2023) | Cook Incorporated | 2023-05-10 |
| Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PT recall (Z-1428-2023) | Cook Incorporated | 2023-05-10 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S005) | Cook Incorporated | 2009-04-02 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S006) | Cook Incorporated | 2009-03-05 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S004) | Cook Incorporated | 2008-05-08 |
| COOK CHORIONIC VILLUS SAMPLING (CVS) SET (P900007/S002) | Cook Incorporated | 2000-06-12 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S001) | Cook Incorporated | 1998-07-08 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007) | Cook Incorporated | 1994-09-30 |