Cleared Traditional

K060016 - THROMCAT THROMBECTOMY CATHETER SYSTEM

K060016 is an FDA 510(k) clearance for THROMCAT THROMBECTOMY CATHETER SYSTEM, manufactured by Kensey Nash Corp.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K060016 · Kensey Nash Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
112d
Days
Class 2
Risk

K060016 is an FDA 510(k) clearance for the THROMCAT THROMBECTOMY CATHETER SYSTEM. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Kensey Nash Corp. (Exton, US). The FDA issued a Cleared decision on April 25, 2006 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - 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.

FDA 510(k) Submission Details - K060016

510(k) Number K060016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2006
Decision Date April 25, 2006
Days to Decision 112 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 125d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MCW Device Classification - Class 2, Special Controls

Product Code MCW Catheter, Peripheral, Atherectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4875
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.

Regulatory Peers - MCW Catheter, Peripheral, Atherectomy

All 141
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K060016.
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