FDA 510(k), K140775, TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM

FDA 510(k), K140775, TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM

Regular price $49.00 USD
Regular price Sale price $49.00 USD
Sale Sold out
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
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

View full details