RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
FDA 510(k) clearance K023918 · decided 2003-03-28
Clearance details
- K-number
- K023918
- Device name
- RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
- Applicant
- Rusch Intl.
- Decision
- Substantially Equivalent
- Date received
- 2002-11-25
- Decision date
- 2003-03-28
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- JOH
- Device class
- 2
- Regulation number
- 868.5800
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Jaffrey, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| RUSCH CrystalClear Tracheostomy Tube, Cuffed, Sterile Pack Crystal Clear Tracheostomy Tube recall (Z-2695-2011) | Teleflex Medical | 2011-06-29 |
| RUSCH Percutwist Set with Crystal Clear Sterile Crystal Clear Tracheostomy Tube is a devic recall (Z-2697-2011) | Teleflex Medical | 2011-06-29 |