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Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr

by Surge Cardiovascular

510(k) K170488

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 NumberK170488 Date10 Aug 2017ClearedStatusActive

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  • Withdrawn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
DWF
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 870.4210
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 Peak Left Ventricular Vent Cannula is a vascular device used for venting the left ventricle during cardiopulmonary bypass procedures. It is available in three sizes: 20 Fr, 18 Fr, and 16 Fr. The device is designed to be inserted at the juncture of the right superior pulmonary vein with the left atrium and passes through the mitral valve.

The Peak Left Ventricular Vent Cannula is intended for use in cardiopulmonary bypass procedures for durations up to 6 hours. It is manufactured by Surge Cardiovascular and has received FDA 510(k) clearance with the product code DWF. The device is classified as a Class II medical device under regulation number 870.4210.

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 purpose of the Peak Left Ventricular Vent Cannula?

    The Peak Left Ventricular Vent Cannula is designed for venting the left ventricle during cardiopulmonary bypass procedures. It is inserted at the juncture of the right superior pulmonary vein with the left atrium and passes through the mitral valve.

  • In what sizes is the Peak Left Ventricular Vent Cannula available?

    The Peak Left Ventricular Vent Cannula is available in three sizes: 20 Fr, 18 Fr, and 16 Fr, allowing for appropriate selection based on patient needs and procedure requirements.

  • How long can the Peak Left Ventricular Vent Cannula be used during procedures?

    The device is intended for use in cardiopulmonary bypass procedures for durations up to 6 hours, providing reliable venting support during standard cardiac surgical procedures.

  • What is the regulatory status of the Peak Left Ventricular Vent Cannula?

    The Peak Left Ventricular Vent Cannula has received FDA 510(k) clearance with product code DWF and is classified as a Class II medical device under regulation number 870.4210.