Cleared Traditional

K160889 - BIB Stent Placement Catheter (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K160889 · NuMED, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 2016
Decision
50d
Days
Class 2
Risk

K160889 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 May 20, 2016 after a review of 50 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all NuMED, Inc. devices

Submission Details

510(k) Number K160889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2016
Decision Date May 20, 2016
Days to Decision 50 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 125d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.