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Intensive Technology, Inc.

United StatesFDA applicant, unverified

Devices
13

What Intensive Technology, Inc. makes

Intensive Technology, Inc. manufactures devices for vascular and intraoperative atherectomy, including peripheral atherectomy systems, intravascular (IVT) introducer sheaths, and guide wires (e.g., 0.014 peripheral and IVT guide wires). Their portfolio also includes hemostasis testing tools like the HEMOCHRON® APTT and Heparin Response Test, as well as mechanical circulatory support devices such as the TEC Rotating Dual Hemovalve and intraoperative atherectomy systems.

The company’s products are regulated under FDA classifications, with devices falling into Class I, Class II, and Class III categories. Authorisation records include 510(k) clearances and Premarket Approvals (PMA), and the devices are listed in the FDA’s regulatory databases. The manufacturer is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue13

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  • Modified Ivt Peripheral Atherectomy Ref K901767

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ivt Introducer Sheath Ref K903463

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Peripheral Atherectomy System Ref K890515

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Aptt By Hemochron(R) Ref K892209

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Modified Ivt Peripheral Atherectomy System Ref K896403

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hemochron(R) Heparin Response Test Ref K904003

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tec Rotating Dual Hemovalve Ref K912664

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Intra-Operative Tec Atherectomy System Ref K922970

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Respa-Trol Ref K810107

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • 0.014 Peripheral Guide Wire Ref K882804

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ivt 0.014 Guide Wire Ref K895903

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ivt Guiding Catheter Ref K911869

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ivt Coronary Atherectomy System (Tec)(R) Ref P910019

    Withdrawn Regimes: PMA, withdrawn Registry: PMA Class:III

Rows 1-13 of 13

Frequently asked questions

How many devices does Intensive Technology, Inc. have in the registry?

The registry currently lists 13 devices for Intensive Technology, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Intensive Technology, Inc.'s devices?

Among its 13 most recently registered devices, Intensive Technology, Inc. has devices listed in FDA 510(k) (12 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Intensive Technology, Inc.'s devices fall under?

Among its 13 most recently registered devices, the classes recorded for Intensive Technology, Inc.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.

What are the newest devices from Intensive Technology, Inc. in the registry?

The most recently registered devices listed for Intensive Technology, Inc. include MODIFIED IVT PERIPHERAL ATHERECTOMY, IVT INTRODUCER SHEATH, PERIPHERAL ATHERECTOMY SYSTEM and APTT BY HEMOCHRON(R).

Generated automatically from registry data and not verified by a human reviewer.