Cleared Traditional

BIB PTA BALLOON CATHETER

K050857 · NuMED, Inc. · Cardiovascular
Jul 2005
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K050857 is an FDA 510(k) clearance for the BIB PTA BALLOON CATHETER, a Catheter, Angioplasty, Peripheral, Transluminal, Dual-balloon (Class II — Special Controls, product code NVM), submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on July 28, 2005, 114 days after receiving the submission on April 5, 2005. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K050857 FDA.gov
FDA Decision Cleared SESU
Date Received April 05, 2005
Decision Date July 28, 2005
Days to Decision 114 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code NVM — Catheter, Angioplasty, Peripheral, Transluminal, Dual-balloon
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250
Definition Percutaneous Transluminal Angioplasty Of Peripheral Vasculature Exclusive Of Coronary Arteries