PACIFIC XTREME PTCA BALLOON DILATATION CATHETER
FDA 510(k) clearance K103464 · decided 2010-12-22
Clearance details
- K-number
- K103464
- Device name
- PACIFIC XTREME PTCA BALLOON DILATATION CATHETER
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-11-24
- Decision date
- 2010-12-22
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- LIT
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Danvers, MA, 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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