Cleared Traditional

K040730 - VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP

K040730 is an FDA 510(k) clearance for VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTA..., manufactured by Vascular Solutions, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K040730 · Vascular Solutions, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
88d
Days
Class 2
Risk

K040730 is an FDA 510(k) clearance for the VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 18, 2004 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K040730

510(k) Number K040730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2004
Decision Date June 18, 2004
Days to Decision 88 days
Submission Type Traditional
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
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 202
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K040730.
COMPASS COMPRESSION ASSIST HANDLE
K053398 · Semler Technologies, Inc. Dba · Mar 2006
VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY
K050146 · Vascular Solutions, Inc. · May 2005
VASOSTASIS VASCULAR CLOSURE SYSTEM
K041486 · Cardiva Medical, Inc. · Oct 2004
COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM
K040615 · Advanced Vascular Dynamics · 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
K040730 · VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP
Download PDF FDA Summary Vascular Solutions, I…