Cleared Special

BIB Stent Placement Catheter

K213915 · NuMED, Inc. · Cardiovascular
Jan 2022
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K213915 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 January 12, 2022, 28 days after receiving the submission on December 15, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K213915 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2021
Decision Date January 12, 2022
Days to Decision 28 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