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Kamar Annulus Dilator and Sizer; Garrett, Cooley, and Debakey Vessel Dilators

by Geister Medizin Technik GmbH

510(k) K030788

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 NumberK030788 Date12 Jul 2003ClearedStatusActive

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  • Withdrawn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)

Full name
Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel Dilators
510(k) Number
FDA Product Code
DWP
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 870.4475
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 Kamar Annulus Dilator and Sizer, along with Garrett, Cooley, and Debakey Vessel Dilators, are surgical vessel dilators. These devices are used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures.

This device is manufactured by Geister Medizin Technik GmbH and has received FDA 510(k) clearance. It is classified as a cardiovascular device under regulation number 870.4475.

Other devices from Geister Medizin Technik GmbH

See all devices from Geister Medizin Technik GmbH →

Questions

AI-generated answers, 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.

  • What are the Kamar, Garrett, Cooley, and Debakey dilators used for?

    These surgical vessel dilators are designed to enlarge or calibrate blood vessels during cardiovascular procedures, specifically coronary artery bypass or angioplasty.

  • What is the regulatory status of these vessel dilators?

    These devices, manufactured by Geister Medizin Technik GmbH, have received FDA 510(k) clearance. They are classified as cardiovascular devices under regulation number 870.4475.

  • Which medical specialty uses these dilators?

    These instruments are categorized under the cardiovascular medical specialty, as they are intended for use in procedures involving the heart and blood vessels, such as coronary artery bypass.