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Universal Coronary Cannula

by Possis Medical, Inc. 510(k)

Active United States

510(k) K831330

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK831330 Date10 Aug 1983ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DWF
Device Class
Class II
Regulation
21 CFR Part 870.4210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 Universal Coronary Cannula is a catheter, cannula and tubing device intended for vascular, cardiopulmonary bypass use. It is classified as a Class II medical device under FDA regulation number 870.4210.

The device received FDA 510(k) clearance (K831330) on August 10, 1983, and is manufactured by Possis Medical, Inc. It is supplied as a non-sterile, reusable device for cardiovascular applications.

Other devices from Possis Medical, Inc.

See all devices from Possis Medical, Inc. →

Questions

AI-generated answers, 6 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 Universal Coronary Cannula used for?

    The Universal Coronary Cannula is intended for vascular and cardiopulmonary bypass use as a catheter, cannula and tubing device in cardiovascular applications.

  • Is the Universal Coronary Cannula sterile or non-sterile when supplied?

    The Universal Coronary Cannula is supplied as a non-sterile device, requiring user sterilization before clinical use in cardiovascular procedures.

  • Can the Universal Coronary Cannula be reused after use?

    The Universal Coronary Cannula is designed as a reusable device, allowing for multiple uses following appropriate cleaning and sterilization protocols.

  • What regulatory pathway was used for the Universal Coronary Cannula?

    The Universal Coronary Cannula received FDA 510(k) clearance under K831330 on August 10, 1983, as a substantially equivalent Class II device.

  • Who manufactures the Universal Coronary Cannula?

    The Universal Coronary Cannula is manufactured by Possis Medical, Inc., located at 4221 Richmond Rd., NW, Walker, MI 49534, United States.