CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER
FDA 510(k) clearance K063563 · decided 2007-03-07
Clearance details
- K-number
- K063563
- Device name
- CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER
- Applicant
- Cordis Europa, N.V.
- Decision
- Substantially Equivalent
- Date received
- 2006-11-28
- Decision date
- 2007-03-07
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- LIT
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Warren, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.