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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 193
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K061075.
MODIFICATION TO: SMITHWICK CAROTID SHUNT
K061484 · Mcpherson Enterprises, Inc. · Dec 2006
BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM
K051817 · Cardiva Medical, Inc. · Dec 2006
SMITHWICK CAROTID SHUNT
K062474 · Mcpherson Enterprises, Inc. · Nov 2006
SYVEKEXCEL
K053300 · Marine Polymer Technologies, Inc. · Mar 2006
COMPASS COMPRESSION ASSIST HANDLE
K053398 · Semler Technologies, Inc. Dba · Mar 2006
VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY
K050146 · Vascular Solutions, Inc. · May 2005
K061075 · BOOMERANG WIRE
Download PDF FDA Summary Cardiva Medical, Inc.