KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING
FDA 510(k) clearance K120985 · decided 2012-12-19
Clearance details
- K-number
- K120985
- Device name
- KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING
- Applicant
- Kimberly-Clark Corp.
- Decision
- Substantially Equivalent
- Date received
- 2012-04-02
- Decision date
- 2012-12-19
- Days to decision
- 261 days
- Clearance type
- Abbreviated
- Product code
- BTR
- Device class
- 2
- Regulation number
- 868.5730
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Roswell, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.