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Fogarty Flexible Calibrator, Reusable

by American Edwards Laboratories 510(k)

Active United States

510(k) K822687

Overview

The Fogarty Flexible Calibrator, Reusable is a surgical vessel dilator designed to enlarge or calibrate blood vessels. This device is a reusable medical instrument, historically associated with the Fogarty catheter family, and is intended for use in cardiovascular procedures to ensure proper vessel diameter and patency.

This device is supplied as a reusable instrument, intended for use in sterile environments such as operating rooms or catheterization labs. It is classified under FDA regulation 870.4475 and holds a Traditional 510(k) clearance with a decision date of October 4, 1982. The product code assigned is DWP, and it is intended for single-patient use per procedure before reprocessing. No MRI safety information is specified, and storage conditions are not detailed in the available data.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK822687 Date4 Oct 1982ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

Full name
Reusable Fogarty Flexible Calibrator
510(k) Number
FDA Product Code
DWP
Device Class
Class II
Regulation
21 CFR Part 870.4475
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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