Kontron Percutaeous Double-Lumen

FDA 510(k) K802924 · Avco Medical Products

Substantially Equivalent

510(k) numberK802924

Submission

Device name
Kontron Percutaeous Double-Lumen
Applicant
Avco Medical Products
Mchenry, IL, US
Received
November 18, 1980
Decision date
March 11, 1981
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

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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
K790241Intra-Aortic Balloon-PumpDSP · Traditional 02/23/1979SE
K781848Pump, Balloon Model 10DSP · Traditional 01/23/1979SE
K770937Pump, Bypass, Pulsatile, AvcoKFM · Traditional 11/17/1977SE
K770821Pump, Balloon, Intra-Aortic, Tri-SegmentDSP · Traditional 05/06/1977SE

Questions and answers

When was Kontron Percutaeous Double-Lumen cleared by the FDA?

Kontron Percutaeous Double-Lumen (K802924) received a 510(k) decision of Substantially Equivalent on March 11, 1981, 113 days after the submission was received.

What is the product code of K802924?

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