MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C
FDA 510(k) clearance K052372 · decided 2005-09-22
Clearance details
- K-number
- K052372
- Device name
- MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C
- Applicant
- Medtronic Perfusion Systems
- Decision
- Substantially Equivalent
- Date received
- 2005-08-30
- Decision date
- 2005-09-22
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- 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.