RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET
FDA 510(k) clearance K122235 · decided 2013-09-06
Clearance details
- K-number
- K122235
- Device name
- RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET
- Applicant
- Teleflexmedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-07-26
- Decision date
- 2013-09-06
- Days to decision
- 407 days
- Clearance type
- Special
- Product code
- JOH
- Device class
- 2
- Regulation number
- 868.5800
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Durham, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.