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510(k) K221414

ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter by Silk Road Medical, Inc. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2022
Date Received
May 16, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by Silk Road Medical, Inc.

  • K230402 — ENROUTE® Transcarotid Neuroprotection System (April 11, 2023)
  • K153485 — ENROUTE Transcarotid Neuroprotection System (March 10, 2016)
  • K143459 — Silk Road Acccess Catheter (April 1, 2015)
  • K143072 — ENROUTE Transcarotid Neuroprotection System (February 9, 2015)
  • K130649 — SILK ROAD ACCESS CATHETER (November 1, 2013)

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  • K241040 — Amethyst HP PTA OTW 0.035 Catheter (December 18, 2024)
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