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510(k) K200700

Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter by Creagh Medical, Ltd. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2020
Date Received
March 17, 2020
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 Creagh Medical, Ltd.

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  • K171251 — 014 Hydrophilic Coated PTA Balloon Dilatation Catheter (September 8, 2017)
  • K113468 — ELM PTA BALLON DILATATION CATHETER (December 20, 2011)
  • K102645 — WILLOW/ELM PTA BALLOON DILATATION CATHETER (December 10, 2010)

Other clearances for product code LIT

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  • K241040 — Amethyst HP PTA OTW 0.035 Catheter (December 18, 2024)
  • K242419 — 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (November 15, 2024)
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  • K241711 — Oscar Peripheral Multifunctional Catheter system (July 11, 2024)
  • K241683 — Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling (July 10, 2024)
  • K241025 — JADE PLUS PTA Balloon Dilatation Catheter (June 11, 2024)