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510(k) K241025

JADE PLUS PTA Balloon Dilatation Catheter by OrbusNeich Medical (Shenzhen) Co., Ltd. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2024
Date Received
April 15, 2024
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 OrbusNeich Medical (Shenzhen) Co., Ltd.

  • K242588 — COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) (January 7, 2025)
  • K233499 — Sapphire NC ULTRA Coronary Dilatation Catheter (August 16, 2024)
  • K233505 — Sapphire ULTRA Coronary Dilatation Catheter (August 15, 2024)
  • K231608 — Teleport XT Microcatheter (January 7, 2024)
  • K211807 — Sapphire NC 24 (October 14, 2021)
  • K202231 — JADE (December 10, 2020)
  • K201794 — Jade (July 28, 2020)

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