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510(k) K173894

Jade PTA Balloon Dilatation Catheter by Orbusneich Medical Trading, Inc. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2018
Date Received
December 21, 2017
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 Trading, Inc.

  • K200269 — Sapphire II PRO (March 4, 2020)
  • K192344 — Sapphire NC Plus Coronary Dilatation Catheter (September 19, 2019)
  • K182713 — Scoreflex PTA Scoring Balloon Catheter (June 11, 2019)
  • K182360 — Teleport Microcatheter (November 9, 2018)
  • K180921 — Sapphire II PRO Balloon Dilatation Catheter (June 28, 2018)
  • K173680 — Sapphire II PRO (March 1, 2018)

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