BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE
FDA 510(k) clearance K131964 · decided 2013-07-24
Clearance details
- K-number
- K131964
- Device name
- BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-06-27
- Decision date
- 2013-07-24
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- DWA
- Device class
- 2
- Regulation number
- 870.4380
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mounds View, 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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