Cleared Special

K120805 - PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE

K120805 is an FDA 510(k) clearance for PROTEUS PTA BALLOON CATHETER WITH EMBOL..., manufactured by Angioslide, Ltd.. 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.

K120805 · Angioslide, Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
28d
Days
Class 2
Risk

K120805 is an FDA 510(k) clearance for the PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Angioslide, Ltd. (Wheat Ridge, US). The FDA issued a Cleared decision on April 13, 2012 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.

FDA 510(k) Submission Details - K120805

510(k) Number K120805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2012
Decision Date April 13, 2012
Days to Decision 28 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
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 381
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K120805.
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
K112797 · Cordis Corp. · May 2012
RIVAL PTA DILATATION CATHETER
K120722 · Bard Peripheral Vascular, Inc. · Apr 2012
ATLAS PTA BALLOON DILATATION CATHETER
K120971 · Bard Peripheral Vascular, Inc. · Apr 2012
FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM
K120738 · Ostial Corporation · Mar 2012
CONQUEST 40 PTA DILATATION CATHETER
K120660 · Bard Peripheral Vascular, Inc. · Mar 2012
CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014)
K120677 · Trireme Medical, Inc. · Mar 2012