PIONEER PLUS CATHETER, MODEL PLUS 120
FDA 510(k) clearance K101777 · decided 2010-07-23
Clearance details
- K-number
- K101777
- Device name
- PIONEER PLUS CATHETER, MODEL PLUS 120
- Applicant
- Medtronic Vascular
- Decision
- Substantially Equivalent
- Date received
- 2010-06-25
- Decision date
- 2010-07-23
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- PDU
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Rosa, CA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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