Cleared Special

K061075 - BOOMERANG WIRE

K061075 is an FDA 510(k) clearance for BOOMERANG WIRE, manufactured by Cardiva Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Special 510(k) pathway after a 137-day FDA review.

K061075 · Cardiva Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
137d
Days
Class 2
Risk

K061075 is an FDA 510(k) clearance for the BOOMERANG WIRE. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Cardiva Medical, Inc. (Moutian View, US). The FDA issued a Cleared decision on September 1, 2006 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 Cardiva Medical, Inc. devices

FDA 510(k) Submission Details - K061075

510(k) Number K061075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2006
Decision Date September 01, 2006
Days to Decision 137 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
12d slower than avg
Panel avg: 125d · This submission: 137d
Pathway characteristics
Modification to existing cleared device.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - DXC Clamp, Vascular

All 94
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K061075.
D-STAT HANDLE, MODEL 8500-053
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K040730 · Vascular Solutions, Inc. · Jun 2004
FEMOSTOP FEMORAL COMPRESSION SYSTEM
K024107 · Radi Medical Systems AB · Dec 2002