Vascucare Angiopump

FDA 510(k) K881780 · Vascucare, Inc.

Substantially Equivalent

510(k) numberK881780

Submission

Device name
Vascucare Angiopump
Applicant
Vascucare, Inc.
Orangeburg, NY, US
Received
April 26, 1988
Decision date
September 28, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DWB – Pump, Blood, Cardiopulmonary Bypass, Roller Type
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4370
Specialty
Cardiovascular
Life-sustaining
Yes

Other 510(k)s with product code DWB

510(k)DeviceApplicantDecision
K162843Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump…DWB · Special Terumo Cardiovascular Systems Corporation11/17/2016SE
K131618Large (6) Roller Pump for Terumo Advanced Perfusion System 1; Large (6) Roller Pump for…DWB · Traditional Terumo Cardiovascular Systems Corporation09/27/2013SE
K112587Advanced Perfusion System 1 (APS1) Tube Clamp Assembly, Roller Pump 6 Inch Classic Color,DWB · Traditional Terumo Cardiovascular Systems Corp.12/19/2011SE
K973237Css-Cardioplegia Safety SystemDWB · Traditional Medtronic Bio-Medicus, Inc.04/27/1998SE
K972321S3 Mast PumpDWB · Traditional Stoeckert Instrumente02/27/1998SE
K971520S3 Cyclic RPM ControlDWB · Traditional Stoeckert Instrumente09/10/1997SE
K960974Cobe Century Perfusion PumpDWB · Traditional Cobe Cardiovascular, Inc.07/14/1997SE
K953904Sarns 9000 Universal Roller PumpDWB · Traditional 3M Health Care, Ltd.04/19/1996SE
K953901Sarns 800 Roller PumpDWB · Traditional 3M Health Care, Sarns04/19/1996SE
K955038Stockert S3 Double Head Pump ModuleDWB · Traditional Stoeckert Instrumente02/21/1996SE

More from Stoeckert Instrumente

510(k)DeviceDecision
K890047Vascucare Percutaneous Angioscopy Delivery SystemLYK · Traditional 06/20/1989SE
K883158Respiratory Airway Tube Monitor (Ratm)BZQ · Traditional 03/06/1989SE

Questions and answers

When was Vascucare Angiopump cleared by the FDA?

Vascucare Angiopump (K881780) received a 510(k) decision of Substantially Equivalent on September 28, 1988, 155 days after the submission was received.

What is the product code of K881780?

The FDA product code is DWB – Pump, Blood, Cardiopulmonary Bypass, Roller Type, a Class II (moderate risk) device regulated under 21 CFR 870.4370.