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FDA 510(k), K111738, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)
FDA 510(k), K111738, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)
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510(K) Number: K111738
Device Name: CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)
Manufacturer: SHIVA ARDAKAMI
Device Classification Name: Catheter, Percutaneous
Regulation Number: DQY
Classification Product Code: 06/21/2011
Date Received: 12/14/2011
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)
Manufacturer: SHIVA ARDAKAMI
Device Classification Name: Catheter, Percutaneous
Regulation Number: DQY
Classification Product Code: 06/21/2011
Date Received: 12/14/2011
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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