RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003
FDA 510(k) clearance K983055 · decided 1998-12-30
Clearance details
- K-number
- K983055
- Device name
- RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003
- Applicant
- Guidant Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-09-01
- Decision date
- 1998-12-30
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- LIT
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.