Skip to content

Proteus PTA Balloon Catheter with Embolic Capture Feature

by Angioslide, Ltd. 4 variants

510(k) K133043

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK133043 Date6 Dec 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LIT
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Proteus PTA Balloon Catheter with Embolic Capture Feature is a catheter, angioplasty, peripheral, transluminal designed for peripheral transluminal angioplasty. It incorporates an embolic capture feature to retrieve embolic material, such as debris or thrombus, during the procedure. The device is intended for use in peripheral arteries, including the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries.

This over-the-wire dual-lumen catheter features a foldable balloon near the distal atraumatic tip. It is supplied as a single-use device and has received FDA 510K clearance under the traditional review pathway. The device is not intended for use in renal, cerebral, coronary, or carotid vasculature. No additional regulatory markings regarding MRI safety or sterility are specified in the provided data.

Other devices from Angioslide, Ltd.

See all devices from Angioslide, Ltd. →