AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE
FDA 510(k) clearance K141233 · decided 2014-06-12
Clearance details
- K-number
- K141233
- Device name
- AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-05-13
- Decision date
- 2014-06-12
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- DTN
- Device class
- 2
- Regulation number
- 870.4400
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- 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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