Cleared Traditional

K101729 - NEOWIRE PTA/PTCA GUIDEWIRE

K101729 is the FDA 510(k) clearance for NEOWIRE PTA/PTCA GUIDEWIRE by Neometrics, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K101729 · Neometrics, Inc. · Cardiovascular device
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Sep 2010
Decision
94d
Days
Class 2
Risk

K101729 is an FDA 510(k) clearance for the NEOWIRE PTA/PTCA GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Neometrics, Inc. (Plymouth, US). The FDA issued a Cleared decision on September 23, 2010 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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.

View all Neometrics, Inc. devices

Submission Details

510(k) Number K101729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2010
Decision Date September 23, 2010
Days to Decision 94 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 125d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 439
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K101729.
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