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510(k) K211349

Selebrek PTCA Balloon Dilatation Catheter by Kossel Medtech (Suzhou) Co., Ltd. — Product Code LOX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2022
Date Received
May 3, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class
Class II
Regulation Number
870.5100
Review Panel
CV
Submission Type

A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.

Other clearances by Kossel Medtech (Suzhou) Co., Ltd.

  • K231402 — HP PTA Balloon Dilatation Catheter (December 20, 2023)
  • K221245 — PTA Balloon Dilatation Catheter (December 14, 2022)
  • K211393 — Selethru(TM) NC PTCA Balloon Dilatation Catheter (July 2, 2021)
  • K182699 — Selethru PTCA Balloon Dilatation Catheter (November 26, 2018)

Other clearances for product code LOX

  • K251970 — Sprinter Legend Rapid Exchange Balloon Dilatation Catheter (January 17, 2026)
  • K242969 — Pantera Pro; Pantera LEO (October 25, 2024)
  • K233499 — Sapphire NC ULTRA Coronary Dilatation Catheter (August 16, 2024)
  • K233505 — Sapphire ULTRA Coronary Dilatation Catheter (August 15, 2024)
  • K233729 — Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon (May 31, 2024)
  • K223189 — Firefighter™ NC Pro PTCA Balloon Catheter (July 21, 2023)
  • K230374 — Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Ballo (June 29, 2023)
  • K230705 — POT PTCA Balloon Dilatation Catheter (April 11, 2023)
  • K223022 — SC HONKYTONK PTCA Balloon Dilatation Catheter (February 15, 2023)
  • K222538 — NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter (December 21, 2022)