Pump, Balloon, Intra-Aortic, Tri-Segment

FDA 510(k) K770821 · Avco Medical Products

Substantially Equivalent

510(k) numberK770821

Submission

Device name
Pump, Balloon, Intra-Aortic, Tri-Segment
Applicant
Avco Medical Products
Mchenry, IL, US
Received
May 4, 1977
Decision date
May 6, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DSP – System, Balloon, Intra-Aortic And Control
Device class
Class II (moderate risk)
Regulation
21 CFR 870.3535
Specialty
Cardiovascular

Other 510(k)s with product code DSP

510(k)DeviceApplicantDecision
K250542AC3™ Range™ Intra-Aortic Balloon PumpDSP · Special Arrow International, LLC03/26/2025SE
K232343AC3™ Series IABPDSP · Special Arrow International, LLC08/30/2023SE
K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPDSP · Special Arrow International, Inc.05/27/2020SE
K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitDSP · Special Arrow International, Inc.04/09/2020SE
K192238AC3 Series Intra-Aortic Balloon Pump (IABP)DSP · Special Arrow International, Teleflex11/12/2019SE
K190101UltraFlex IABDSP · Traditional Arrow International, Inc.06/28/2019SE
K190117Fiberoptix IABDSP · Traditional Arrow International, Inc.06/13/2019SE
K181122CARDIOSAVE Intra-Aortic Balloon PumpDSP · Special Datascope Corp.05/31/2018SE
K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDSP · Special Datascope Corp.10/12/2017SE
K162820AC3 Series IABP SystemDSP · Traditional Arrow International, Inc.03/31/2017SE

More from Arrow International, Inc.

510(k)DeviceDecision
K802924Kontron Percutaeous Double-LumenDSP · Traditional 03/11/1981SE
K790241Intra-Aortic Balloon-PumpDSP · Traditional 02/23/1979SE
K781848Pump, Balloon Model 10DSP · Traditional 01/23/1979SE
K770937Pump, Bypass, Pulsatile, AvcoKFM · Traditional 11/17/1977SE

Questions and answers

When was Pump, Balloon, Intra-Aortic, Tri-Segment cleared by the FDA?

Pump, Balloon, Intra-Aortic, Tri-Segment (K770821) received a 510(k) decision of Substantially Equivalent on May 6, 1977, 2 days after the submission was received.

What is the product code of K770821?

The FDA product code is DSP – System, Balloon, Intra-Aortic And Control, a Class II (moderate risk) device regulated under 21 CFR 870.3535.