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510(k) K230191

Arise™ UHP Dilatation Catheter by Creagh Medical, Ltd. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2023
Date Received
January 24, 2023
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.

  • K200700 — Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplast (May 14, 2020)
  • K180007 — 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (April 19, 2018)
  • 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)

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  • K243704 — Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon D (February 27, 2025)
  • K241040 — Amethyst HP PTA OTW 0.035 Catheter (December 18, 2024)
  • K242419 — 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (November 15, 2024)
  • K241740 — Finesse Injectable™ PTA Balloon Dilatation Catheter (July 16, 2024)
  • 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)