510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050857Unknown

Bib Pta Balloon Catheter

Numed Inc, Hopkinton NY / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050857 is the FDA 510(k) clearance record for BIB PTA BALLOON CATHETER, a class II device, cleared for NuMED, Inc. on under FDA product code NVM (Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon). FDA's definition for product code NVM reads: "Percutaneous transluminal angioplasty of peripheral vasculature exclusive of coronary arteries". FDA records list 46 510(k) clearances for NuMED, Inc., from to . As of , FDA records show one recall naming K050857.

Clearance record

Decision date
Received
(114 days to decision)
Product code
NVM Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
NuMED, Inc. 2880 Main St., Hopkinton NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NVM

Trailing 12 months

FDA records hold no clearances under product code NVM in the trailing twelve months.

FDA records show no clearances under product code NVM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NVM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260