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META III

by Hittman Medical Systems

510(k) K790300

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 NumberK790300 Date27 Mar 1979ClearedStatusActive

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  • Withdrawn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
DPS
Device Class
Class II
Regulation
21 CFR Part 870.2340
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.

META III is a cardiovascular device. It received FDA 510(k) clearance as substantially equivalent to a predicate device.

The device was cleared through a traditional 510(k) pathway. It is classified under product code DPS and regulation number 870.1025, with device class II. The clearance was granted on March 27, 1979, under K790300.

Other devices from Hittman Medical Systems

Questions

AI-generated answers, 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.

  • What is the primary purpose or intended use of the META III device as described in its regulatory submission?

    The META III device is a cardiovascular device cleared under the FDA’s 510(k) pathway as substantially equivalent to a predicate device. Its classification under product code DPS (Cardiovascular Devices) and advisory committee designation (CV) indicates it is designed for use in cardiovascular procedures, though the exact clinical application is not specified beyond this regulatory context.

  • How was the META III device’s regulatory clearance process conducted, and what type of review did it undergo?

    The META III device received FDA clearance through a traditional 510(k) pathway, which involves a comparison to a legally marketed predicate device to demonstrate substantial equivalence. The review was conducted by the Cardiovascular (CV) advisory committee, and the decision was finalized on March 27, 1979, under the classification of Class II.

  • Is the META III device intended for single-use or reusable applications, and does the manufacturer provide any guidance on this?

    The provided regulatory data does not explicitly state whether the META III device is intended for single-use or reuse. Since the description focuses solely on the device’s classification, clearance pathway, and manufacturer details, no information about usage cycles or reprocessing guidelines is included.

  • What is the manufacturer’s address for the META III device, and where was the regulatory submission originally filed?

    The manufacturer, Hittman Medical Systems, is based at 803 N. Front St. Suite 3, McHenry, IL 60050, USA. The original FDA submission for the META III device was filed on February 12, 1979, under the 510(k) number K790300, with the clearance granted on March 27, 1979.