Ultra Iabp Catheter Kit, Models IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20

FDA 510(k) K082746 · Insightra Medical, Inc.

Substantially Equivalent

510(k) numberK082746

Submission

Device name
Ultra Iabp Catheter Kit, Models IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20
Applicant
Insightra Medical, Inc.
Irvine, CA, US
Received
September 19, 2008
Decision date
January 12, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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

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K250542AC3™ Range™ Intra-Aortic Balloon PumpDSP · Special Arrow International, LLC03/26/2025SE
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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.

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K140967Freedom Inguinal Hernia Repair IMPLANT-25MM/40MM/40MM with Extended DiskFTL · Special 06/10/2014SE
K113552Freedom Inguinal Hernia ImplantFTL · Traditional 08/23/2012SE

Questions and answers

When was Ultra Iabp Catheter Kit, Models IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 cleared by the FDA?

Ultra Iabp Catheter Kit, Models IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 (K082746) received a 510(k) decision of Substantially Equivalent on January 12, 2009, 115 days after the submission was received.

What is the product code of K082746?

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