PIONEER PLUS CATHETER
FDA 510(k) clearance K081804 · decided 2008-08-05
Clearance details
- K-number
- K081804
- Device name
- PIONEER PLUS CATHETER
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-06-26
- Decision date
- 2008-08-05
- Days to decision
- 40 days
- Clearance type
- Traditional
- 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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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total recall (Z-2718-2015) | Volcano Corporation | 2015-09-02 |
| Pioneer Plus Catheter PPlus 120 dual lumen device, inserted through a 6F introducer sheath recall (Z-0864-2011) | Medtronic CardioVascular | 2011-01-06 |
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|---|---|---|
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