Cleared Special

K061843 - VENTURE WIRE CONTROL CATHETER, MODEL WCC

K061843 is an FDA 510(k) clearance for VENTURE WIRE CONTROL CATHETER, manufactured by St Jude Medical. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 32-day FDA review.

K061843 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
32d
Days
Class 2
Risk

K061843 is an FDA 510(k) clearance for the VENTURE WIRE CONTROL CATHETER, MODEL WCC. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by St Jude Medical (Maple Grove, US). The FDA issued a Cleared decision on August 1, 2006 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 St Jude Medical devices

FDA 510(k) Submission Details - K061843

510(k) Number K061843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2006
Decision Date August 01, 2006
Days to Decision 32 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 125d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
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 - DQY Catheter, Percutaneous

All 799
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