Cleared Traditional

K133043 - PROTEUS PTA BALLOON CATHETER WITH EMBOL...

K133043 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 Traditional 510(k) pathway after a 71-day FDA review.

K133043 · Angioslide, Ltd. · Cardiovascular device
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Dec 2013
Decision
71d
Days
Class 2
Risk

K133043 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 December 6, 2013 after a review of 71 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. 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 Angioslide, Ltd. devices

FDA 510(k) Submission Details - K133043

510(k) Number K133043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2013
Decision Date December 06, 2013
Days to Decision 71 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
54d faster than avg
Panel avg: 125d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 278
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