Cleared Traditional

K050857 - BIB PTA BALLOON CATHETER (FDA 510(k) Clearance)

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

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

K050857 is an FDA 510(k) clearance for the BIB PTA BALLOON 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 July 28, 2005 after a review of 114 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K050857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 125d · This submission: 114d
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.