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Edslab Occlusion Balloon Catheter

by American Edwards Laboratories

510(k) K873485

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 NumberK873485 Date3 Dec 1987ClearedStatusActive

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  • Withdrawn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)

Full name
Edslab (R) Occlusion Balloon Catheter
510(k) Number
FDA Product Code
DQY
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

An occlusion balloon catheter is a percutaneous catheter introduced into a vein or artery through the skin using a dilator and a sheath or guide wire. It is designed for temporary vascular occlusion.

This device is supplied by American Edwards Laboratories and was cleared through the FDA 510(k) pathway on December 3, 1987, under product code DQY. It is classified as a Class 2 device with the regulation number 870.1250 and classification name Catheter.

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Questions

AI-generated answers, 27 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 EDSLAB (R) Occlusion Balloon Catheter used for?

    The EDSLAB (R) Occlusion Balloon Catheter is designed for temporary vascular occlusion in veins or arteries. It is introduced percutaneously using a dilator, sheath, or guide wire to block blood flow temporarily during procedures.

  • How is the EDSLAB (R) Occlusion Balloon Catheter supplied and cleared for use?

    The device is supplied by American Edwards Laboratories and received FDA 510(k) clearance on December 3, 1987, under K873485 and product code DQY. It is classified as a Class 2 device under regulation 870.1250.

  • Is the EDSLAB (R) Occlusion Balloon Catheter intended for single-use or reuse?

    The device data does not specify whether the EDSLAB (R) Occlusion Balloon Catheter is single-use or reusable. Reusability must be determined from the manufacturer's labeling or instructions for use, which are not included in the provided data.