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510(k) K050857

BIB PTA BALLOON CATHETER by NuMED, Inc. — Product Code NVM

K050857 is an FDA 510(k) premarket notification submitted by NuMED, Inc. for the device "BIB PTA BALLOON CATHETER". The FDA issued a decision of SESU on July 28, 2005. The device falls under product code NVM (Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon), a Class II device regulated under 21 CFR 870.1250. NuMED, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
July 28, 2005
Date Received
April 5, 2005
Clearance Type
Traditional
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)
  • 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)

Other clearances for product code NVM

  • K213915 — BIB Stent Placement Catheter (January 12, 2022)
  • K211134 — BIB Stent Placement Catheter (May 27, 2021)
  • K161451 — BIB Stent Placement Catheter (September 22, 2016)
  • K160889 — BIB Stent Placement Catheter (May 20, 2016)

FDA data resources