Cleared Special

K072167 - COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE

K072167 is an FDA 510(k) clearance for COMFORTPRESS VASCULAR COMPRESSION ASSIS..., 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 31-day FDA review.

K072167 · Advanced Vascular Dynamics · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
31d
Days
Class 2
Risk

K072167 is an FDA 510(k) clearance for the COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE. 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 September 6, 2007 after a review of 31 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 - K072167

510(k) Number K072167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2007
Decision Date September 06, 2007
Days to Decision 31 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
94d faster than avg
Panel avg: 125d · This submission: 31d
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 K072167.
HEARTSTRING III PROXIMAL SEAL SYSTEM
K080169 · Guidant Corporation, Cardiac Surgery · Feb 2008
SIBEL SA VASCULAR CLAMP
K072834 · Surgical Instruments Belgium SA · Jan 2008
BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM
K072297 · Cardiva Medical, Inc. · Sep 2007
INNOVASA STAT*SEAL TOPICAL HEMOSTAT
K071225 · Innovasa, Inc. · Aug 2007
VITALCOR FEATHERWEIGHT VASCULAR CLAMPS
K070661 · Vitalcor, Inc. · Aug 2007
PORTACLAMP FLEX
K070380 · Cardio Life Research, S.A. · Jun 2007