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510(k) K232013

Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040) by Goodman Co., Ltd. — Product Code PNO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2024
Date Received
July 6, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous, Cutting/Scoring
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material

Other clearances by Goodman Co., Ltd.

  • K243944 — Aperta NSE PTA Balloon Dilatation Catheter (April 22, 2025)
  • K010763 — GOODNET (May 25, 2001)

Other clearances for product code PNO

  • K260012 — UltraScore™ Focused Force PTA Balloon (February 4, 2026)
  • K243944 — Aperta NSE PTA Balloon Dilatation Catheter (April 22, 2025)
  • K242254 — D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter (April 21, 2025)
  • K241478 — Tri-Wedge PTA Scoring Balloon Dilatation Catheter (October 22, 2024)
  • K232258 — XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter (June 17, 2024)
  • K232207 — D·Kutting™ PTA Scoring Balloon Dilatation Catheter (March 7, 2024)
  • K221986 — XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP (October 18, 2022)
  • K220704 — Serranator PTA Serration Balloon Catheter (May 4, 2022)
  • K213728 — Serranator PTA Serration Balloon Catheter (December 15, 2021)
  • K203437 — Serranator PTA Serration Balloon Catheter (December 22, 2020)