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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: DSP FDA class 2

    System, Balloon, Intra-Aortic And Control

    Cardiovascular

    View full classification →

    The Intra-Aortic Balloon System and Control is a cardiovascular support device consisting of a balloon catheter placed in the descending aorta and an external control console that inflates and deflates the balloon in synchrony with the cardiac cycle to reduce cardiac workload and improve coronary perfusion. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DSP and it is regulated under 21 CFR 870.3535 within the Cardiovascular medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    AC3™ Range™ Intra-Aortic Balloon Pump
    AC3™ Series IABP
    AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
    Arrow FiberOptix Intra-Aortic Balloon Catheter Kit
    AC3 Series Intra-Aortic Balloon Pump (IABP)
    UltraFlex IAB
    Fiberoptix IAB
    CARDIOSAVE Intra-Aortic Balloon Pump
    CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump
    AC3 Series IABP System
    CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case
    CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
    MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES
    SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES
    MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER
    CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP
    SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES
    DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02
    ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20
    SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE
    DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM
    SUPRACOR BALLOON CATHETER
    AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES
    DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES
    INTRA-AORTIC BALLOON (IAB)
    CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX
    DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX
    ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840
    DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S
    MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B
    ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP
    ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U
    DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320
    MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC
    ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
    DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329
    8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER
    BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP
    Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters
    BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP
    IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U
    BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS
    DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES
    DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES
    BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS
    40 CC GRANDE
    ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1)
    8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S
    30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL
    40 CC SUMO

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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