BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER
FDA 510(k) clearance K112562 · decided 2011-12-15
Clearance details
- K-number
- K112562
- Device name
- BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER
- Applicant
- Kimberly-Clark
- Decision
- Substantially Equivalent
- Date received
- 2011-09-26
- Decision date
- 2011-12-15
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- OYI
- Device class
- 1
- Regulation number
- 868.6810
- 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.