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Percutaneous Balloon

by Smec, Inc.

510(k) K832753

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK832753 Date13 Oct 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
DSP
Device Class
Class II
Regulation
21 CFR Part 870.3535
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 device is a percutaneous balloon, a type of intra-aortic balloon system used in cardiovascular applications. It is designed for percutaneous transluminal use to dilate or support vascular structures, particularly in the aorta, based on its classification and intended use as a balloon catheter system.

It was cleared via the FDA 510(k) pathway under K832753, with product code DSP and regulation number 870.3535, and is classified as a Class II device. The device is supplied by Smec, Inc., and its authorization is based on substantial equivalence to a legally marketed predicate device.

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