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AVE 4F SiteSeer Cardiovascular Angiographic Catheter

by Arterial Vascular Engineering, Inc.

510(k) K984627

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 NumberK984627 Date27 Jul 1999ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The AVE 4F SiteSeer Cardiovascular Angiographic Catheter is an intravascular diagnostic catheter used in the cardiovascular system. It functions by being inserted into the heart and vessels to record intracardiac pressures, sample blood, and deliver substances such as radiopaque contrast media.

This device is supplied as a sterile, single-use catheter and is classified as a Class II medical device under product code DQO. It received FDA 510(k) clearance (K984627) on July 27, 1999, and is substantially equivalent to a predicate device. The catheter is intended for use in cardiovascular diagnostic procedures and is manufactured by Arterial Vascular Engineering, Inc. in Billerica, Massachusetts.

Other devices from Arterial Vascular Engineering, Inc.

Questions

AI-generated answers, 1 Oct 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 AVE 4F SiteSeer Cardiovascular Angiographic Catheter used for?

    It is used to record intracardiac pressures, sample blood, and deliver radiopaque contrast media during cardiovascular diagnostic procedures by being inserted into the heart and blood vessels.

  • Is the AVE 4F SiteSeer catheter sterile and single-use?

    Yes, the device is supplied as a sterile, single-use catheter, meaning it is intended for one procedure only and should not be reprocessed or reused to maintain sterility and patient safety.

  • What regulatory pathway was used for the AVE 4F SiteSeer catheter?

    The device received FDA 510(k) clearance under K984627 on July 27, 1999, and was determined to be substantially equivalent to a predicate device, which is the standard pathway for moderate-risk Class II devices.