Cleared Special

BIB Stent Placement Catheter

K211134 · NuMED, Inc. · Cardiovascular
May 2021
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K211134 is an FDA 510(k) clearance for the BIB Stent Placement 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 May 27, 2021, 41 days after receiving the submission on April 16, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K211134 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2021
Decision Date May 27, 2021
Days to Decision 41 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement

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