PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM
FDA 510(k) clearance K120953 · decided 2012-12-10
Clearance details
- K-number
- K120953
- Device name
- PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM
- Applicant
- Tlelflex Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-03-30
- Decision date
- 2012-12-10
- Days to decision
- 255 days
- Clearance type
- Traditional
- Product code
- CAC
- Device class
- 2
- Regulation number
- 868.5830
- 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.