Cleared Special

K040615 - COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM

K040615 is an FDA 510(k) clearance for COMPRESSAR SUPERCOMFORT DISC AND STRONG..., manufactured by Advanced Vascular Dynamics. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Special 510(k) pathway after a 84-day FDA review.

K040615 · Advanced Vascular Dynamics · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
84d
Days
Class 2
Risk

K040615 is an FDA 510(k) clearance for the COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Advanced Vascular Dynamics (Portland, US). The FDA issued a Cleared decision on June 1, 2004 after a review of 84 days - a notably fast clearance cycle.

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. 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.

FDA 510(k) Submission Details - K040615

510(k) Number K040615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2004
Decision Date June 01, 2004
Days to Decision 84 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
41d faster than avg
Panel avg: 125d · This submission: 84d
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 192
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K040615.
VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY
K050146 · Vascular Solutions, Inc. · May 2005
VASOSTASIS VASCULAR CLOSURE SYSTEM
K041486 · Cardiva Medical, Inc. · Oct 2004
VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP
K040730 · Vascular Solutions, Inc. · Jun 2004
PORTACLAMP
K033085 · Cardio Life Research, S.A. · Apr 2004
CSTAT, MODELS 09-0014-01 AND 09-0014-02
K032125 · Vascular Control Systems, Inc. · Feb 2004
TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03
K031812 · Vascular Control Systems, Inc. · Dec 2003