Cleared Special

K100921 - ADMIRAL XTREME PTA BALLOON DILATATION C...

K100921 is an FDA 510(k) clearance for ADMIRAL XTREME PTA BALLOON DILATATION C..., manufactured by Invatec S.P.A.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Special 510(k) pathway after a 28-day FDA review.

K100921 · Invatec S.P.A. · Cardiovascular device
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Apr 2010
Decision
28d
Days
Class 2
Risk

K100921 is an FDA 510(k) clearance for the ADMIRAL XTREME PTA BALLOON DILATATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Invatec S.P.A. (Bethlehem, US). The FDA issued a Cleared decision on April 30, 2010 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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.

View all Invatec S.P.A. devices

FDA 510(k) Submission Details - K100921

510(k) Number K100921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2010
Decision Date April 30, 2010
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

LIT Device Classification - Class 2, Special Controls

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 262
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