Skip to content

Polymed Lab Arterial Embolectomy Catheter

by Polymed Laboratories

510(k) K850015

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 NumberK850015 Date19 Jun 1985ClearedStatusActive

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  • Withdrawn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
DXE
Device Class
Class II
Regulation
21 CFR Part 870.5150
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 Polymed Lab Arterial Embolectomy Catheter is a balloon-tipped catheter used to remove thromboemboli, which are blood clots that have migrated through the vascular system. This device is classified as a Class II catheter for embolectomy procedures in the cardiovascular specialty.

The device is supplied by Polymed Laboratories and received FDA 510(k) clearance in 1985 with the product code DXE. It is regulated under number 870.5150 and was reviewed by the Cardiovascular advisory committee. The device is intended for use in cardiovascular procedures to remove blood clots from blood vessels.

Other devices from Polymed Laboratories

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 Polymed Lab Arterial Embolectomy Catheter used for?

    The Polymed Lab Arterial Embolectomy Catheter is a balloon-tipped catheter designed to remove thromboemboli, which are blood clots that have migrated through the vascular system, during cardiovascular procedures.

  • How is the Polymed Lab Arterial Embolectomy Catheter supplied?

    The device is supplied by Polymed Laboratories and is classified as a Class II catheter for embolectomy procedures in the cardiovascular specialty.

  • What is the regulatory status of the Polymed Lab Arterial Embolectomy Catheter?

    The Polymed Lab Arterial Embolectomy Catheter received FDA 510(k) clearance in 1985 with the product code DXE and is regulated under number 870.5150. It was reviewed by the Cardiovascular advisory committee.

  • Is the Polymed Lab Arterial Embolectomy Catheter single-use or reusable?

    The device data does not specify whether the Polymed Lab Arterial Embolectomy Catheter is single-use or reusable. This information should be obtained directly from the manufacturer or product documentation.