Cleared Traditional Expedited

TEMPORARY LIMB SALVAGE SHUNT (K070323) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K070323 · Vascutek, Ltd. · Cardiovascular device
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Feb 2007
Decision
13d
Days
Class 2
Risk

K070323 is an FDA 510(k) clearance for the TEMPORARY LIMB SALVAGE SHUNT. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Vascutek, Ltd. (Renfrewshire, Glasgow, GB). The FDA issued a Cleared decision on February 15, 2007 after a review of 13 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.

View all Vascutek, Ltd. devices

Submission Details

510(k) Number K070323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2007
Decision Date February 15, 2007
Days to Decision 13 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 125d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 40
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K070323.
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
K113182 · Edwards Lifesciences, LLC · Dec 2011
EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER
K112694 · Edwards Lifesciences, LLC · Oct 2011
TR BAND
K070423 · Terumo Medical Corp. · Mar 2007
SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING
K062569 · Datascope Corp. · Feb 2007
KSEA DEPLOYABLE CARDIOVASCULAR CLAMP
K014277 · KARL STORZ Endoscopy-America, Inc. · Dec 2002
KSEA DION-GRACIA SET
K010785 · KARL STORZ Endoscopy-America, Inc. · Aug 2001