Cleared Traditional

K072834 - SIBEL SA VASCULAR CLAMP

K072834 is an FDA 510(k) clearance for SIBEL SA VASCULAR CLAMP, manufactured by Surgical Instruments Belgium SA. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K072834 · Surgical Instruments Belgium SA · Cardiovascular device
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Jan 2008
Decision
98d
Days
Class 2
Risk

K072834 is an FDA 510(k) clearance for the SIBEL SA VASCULAR CLAMP. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Surgical Instruments Belgium SA (Claremont, US). The FDA issued a Cleared decision on January 9, 2008 after a review of 98 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Surgical Instruments Belgium SA devices

FDA 510(k) Submission Details - K072834

510(k) Number K072834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2007
Decision Date January 09, 2008
Days to Decision 98 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
27d faster than avg
Panel avg: 125d · This submission: 98d
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 111
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K072834.
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K070323 · Vascutek, Ltd. · Feb 2007