NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)
FDA 510(k) clearance K121667 · decided 2012-08-13
Clearance details
- K-number
- K121667
- Device name
- NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2012-06-06
- Decision date
- 2012-08-13
- Days to decision
- 68 days
- Clearance type
- Special
- Product code
- LOX
- Device class
- 2
- Regulation number
- 870.5100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.