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Physio-Probe-High Permeability Cath.

by Research Industries Corp.

510(k) K833433

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 NumberK833433 Date29 Dec 1983ClearedStatusActive

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  • Withdrawn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
DQY
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 Physio-Probe High Permeability Cath. is a catheter designed for cardiovascular applications, classified under product code DQY (21 CFR 870.1250) as a substantially equivalent device. It is intended for use in procedures requiring fluid exchange or monitoring within the circulatory system, leveraging its high permeability properties for targeted interventions.

This device is supplied as a single-use medical instrument, cleared by the FDA under 510(k) pathway (K833433) in 1983. It is intended for use in controlled clinical settings, adhering to standard sterility and handling protocols for catheters. No additional regulatory status beyond the stated 510(k) clearance is implied.

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