Cleared Special

PV 1900 SYNCHRO 0.016 GUIDEWIRE (K050964) - FDA 510(k) Clearance

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

K050964 · Boston Scientific - Precision Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
56d
Days
Class 2
Risk

K050964 is an FDA 510(k) clearance for the PV 1900 SYNCHRO 0.016 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 June 13, 2005 after a review of 56 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 K050964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2005
Decision Date June 13, 2005
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
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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