Cleared Traditional

3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON (K093515) - FDA 510(k) Clearance

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

K093515 · Brivant, Ltd. · Cardiovascular device
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Feb 2010
Decision
95d
Days
Class 2
Risk

K093515 is an FDA 510(k) clearance for the 3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT .... Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Brivant, Ltd. (Galway, IE). The FDA issued a Cleared decision on February 16, 2010 after a review of 95 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 Brivant, Ltd. devices

Submission Details

510(k) Number K093515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2009
Decision Date February 16, 2010
Days to Decision 95 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
30d faster than avg
Panel avg: 125d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 763
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