Who is the manufacturer of BETTER-VENTER?

Circulatory Technology, Inc. submitted the Traditional clearance for BETTER-VENTER (K961594).

What is the FDA product code for BETTER-VENTER?

DWF. It is classified under 21 CFR 870.4210 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for BETTER-VENTER?

510(k) clearance (submission type: Traditional).

BETTER-VENTER

K961594 · Circulatory Technology, Inc. · DWF · Sep 5, 1996 · Cardiovascular

Device Facts

Record ID	K961594
Device Name	BETTER-VENTER
Applicant	Circulatory Technology, Inc.
Product Code	DWF · Cardiovascular
Decision Date	Sep 5, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.4210
Device Class	Class 2

Regulatory Classification

Identification

A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.