AUTOLOG AUTOTRANSFUSION SYSTEM
FDA 510(k) clearance K093535 · decided 2010-03-22
Clearance details
- K-number
- K093535
- Device name
- AUTOLOG AUTOTRANSFUSION SYSTEM
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-11-16
- Decision date
- 2010-03-22
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- CAC
- Device class
- 2
- Regulation number
- 868.5830
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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