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510(k) K181023

Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter by Meril Life Sciences Private Limited — Product Code LOX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2018
Date Received
April 17, 2018
Clearance Type
Special
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 Meril Life Sciences Private Limited

  • K190619 — Aspiron(TM) Aspiration Catheter (April 29, 2019)
  • K160961 — Mozec NC-Rx PTCA Baloon Dilatation Catheter (July 30, 2016)
  • K131169 — MOZEC - RX PTCA BALLOON DILATATION CATHETER (December 24, 2013)

Other clearances for product code LOX

  • K252116 — Firefighter™ Pro PTCA Balloon Catheter (April 7, 2026)
  • K254022 — FLASH Flex™ Aorto-Ostial Angioplasty System (April 2, 2026)
  • K252295 — Ryurei (March 27, 2026)
  • 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)