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FDA 510(k), K140775, TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM
FDA 510(k), K140775, TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM
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510(K) Number: K140775
Device Name: TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM
Manufacturer: SPECTRANETICS CORPORATION
Device Classification Name: catheter, peripheral, atherectomy
Regulation Number: 870.4875
Classification Product Code: MCW
Date Received: 03/28/2014
Decision Date: 07/23/2014
Regulation Medical Specialty: Cardiovascular
Device Name: TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM
Manufacturer: SPECTRANETICS CORPORATION
Device Classification Name: catheter, peripheral, atherectomy
Regulation Number: 870.4875
Classification Product Code: MCW
Date Received: 03/28/2014
Decision Date: 07/23/2014
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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