Cleared Special

K213915 - BIB Stent Placement Catheter (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

K213915 is an FDA 510(k) clearance for the BIB Stent Placement Catheter. Classified as Catheter, Angioplasty, Peripheral, Transluminal, Dual-balloon (product code NVM), Class II - Special Controls.

Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on January 12, 2022 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all NuMED, Inc. devices

Submission Details

510(k) Number K213915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NVM Catheter, Angioplasty, Peripheral, Transluminal, Dual-balloon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition Percutaneous Transluminal Angioplasty Of Peripheral Vasculature Exclusive Of Coronary Arteries
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.