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510(k) K211134

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2021
Date Received
April 16, 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.

  • K213915 — BIB Stent Placement Catheter (January 12, 2022)
  • K211910 — Z-6 Atrioseptostomy Catheter (July 19, 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

  • K213915 — BIB Stent Placement Catheter (January 12, 2022)
  • K161451 — BIB Stent Placement Catheter (September 22, 2016)
  • K160889 — BIB Stent Placement Catheter (May 20, 2016)
  • K050857 — BIB PTA BALLOON CATHETER (July 28, 2005)