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Scimed Expo Angiographic Catheter

by Scimed Life Systems, Inc.

510(k) K951720

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 NumberK951720 Date22 Jun 1995ClearedStatusActive

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  • Withdrawn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
DQO
Device Class
Class II
Regulation
21 CFR Part 870.1200
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Scimed Expo Angiographic Catheter is a device designed to provide a pathway for delivering contrast in angiographic procedures. It is intended for use in cardiovascular applications to facilitate diagnostic imaging and interventions.

The device is supplied by Scimed Life Systems, Inc. and received FDA 510(k) clearance on June 22, 1995 (K951720). It is classified under product code DQO and was reviewed by the Cardiovascular advisory committee. The device is available in various sizes as specified by the manufacturer.

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Questions

AI-generated answers, 24 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 Scimed Expo Angiographic Catheter used for?

    The Scimed Expo Angiographic Catheter is designed to provide a pathway for delivering contrast in angiographic procedures. It is intended for use in cardiovascular applications to facilitate diagnostic imaging and interventions.

  • How is the Scimed Expo Angiographic Catheter supplied?

    The device is supplied by Scimed Life Systems, Inc. It is available in various sizes as specified by the manufacturer to accommodate different clinical needs and procedures.

  • What is the regulatory status of the Scimed Expo Angiographic Catheter?

    The Scimed Expo Angiographic Catheter received FDA 510(k) clearance on June 22, 1995 (K951720). It is classified under product code DQO and was reviewed by the Cardiovascular advisory committee.

  • Is the Scimed Expo Angiographic Catheter single-use or reusable?

    The device data does not specify whether the Scimed Expo Angiographic Catheter is designed for single-use or multiple uses. Clinicians should refer to the manufacturer's instructions for use to determine the appropriate handling and disposal protocols.