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510(k) K213915

BIB Stent Placement Catheter by NuMED, Inc. — Product Code NVM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2022
Date Received
December 15, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Percutaneous transluminal angioplasty of peripheral vasculature exclusive of coronary arteries

Other clearances by NuMED, Inc.

  • K211910 — Z-6 Atrioseptostomy Catheter (July 19, 2021)
  • K211134 — BIB Stent Placement Catheter (May 27, 2021)
  • K190974 — D'Vill Introducer (May 14, 2019)
  • K171206 — D'Vill Introducer (October 20, 2017)
  • K161451 — BIB Stent Placement Catheter (September 22, 2016)
  • K160598 — REBOA Balloon Catheter (June 20, 2016)
  • K160889 — BIB Stent Placement Catheter (May 20, 2016)
  • K131869 — PTS-X SIZING BALLOON CATHETER (August 8, 2013)
  • K122012 — Z-MED Z-MED II (October 4, 2012)
  • K121859 — TYSHAK NUCLEUS (August 31, 2012)

Other clearances for product code NVM

  • K211134 — BIB Stent Placement Catheter (May 27, 2021)
  • K161451 — BIB Stent Placement Catheter (September 22, 2016)
  • K160889 — BIB Stent Placement Catheter (May 20, 2016)
  • K050857 — BIB PTA BALLOON CATHETER (July 28, 2005)