Cleared Traditional

K013913 - PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM

K013913 is an FDA 510(k) clearance for PERCUSURGE GUARDWIRE PLUS TEMPORARY OCC..., manufactured by Medtronic Percusurge, Inc.. The device is a Class 2 Cardiovascular device with product code NFA cleared through the Traditional 510(k) pathway after a 353-day FDA review.

K013913 · Medtronic Percusurge, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
353d
Days
Class 2
Risk

K013913 is an FDA 510(k) clearance for the PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM. Classified as Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection (product code NFA), Class II - Special Controls.

Submitted by Medtronic Percusurge, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 15, 2002 after a review of 353 days - an unusually long review period, suggesting complex equivalence evaluation.

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

View all Medtronic Percusurge, Inc. devices

FDA 510(k) Submission Details - K013913

510(k) Number K013913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2001
Decision Date November 15, 2002
Days to Decision 353 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
228d slower than avg
Panel avg: 125d · This submission: 353d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFA Device Classification - Class 2, Special Controls

Product Code NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection

All 16
Devices cleared under the same product code (NFA) and FDA review panel - the closest regulatory comparables to K013913.
TRIACTIV SYSTEM
K042040 · Kensey Nash Corp. · Mar 2005
MODIFICATION TO EXPORT ASPIRATION CATHETER
K030201 · Medtronic Vascular · Mar 2003
GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
K023878 · Medtronic Vascular · Jan 2003
EXPORT ASPIRATION CATHETER
K023303 · Medtronic Vascular · Oct 2002