Cleared Special

PVS 2000 SYNCHRO2 GUIDEWIRE (K053268) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K053268 · Boston Scientific - Precision Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
110d
Days
Class 2
Risk

K053268 is an FDA 510(k) clearance for the PVS 2000 SYNCHRO2 GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Boston Scientific - Precision Vascular (West Valley City, US). The FDA issued a Cleared decision on March 13, 2006 after a review of 110 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boston Scientific - Precision Vascular devices

Submission Details

510(k) Number K053268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2005
Decision Date March 13, 2006
Days to Decision 110 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 125d · This submission: 110d
Pathway characteristics
Modification to existing cleared device.

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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