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Scimed Life Systems, Inc.

United StatesFDA applicant, unverified

Devices
111

What Scimed Life Systems, Inc. makes

Scimed Life Systems, Inc. manufactures guide catheters and guide wires for percutaneous transluminal coronary angioplasty (PTCA) procedures, including the Triguide guiding catheter series in 7FR and 8FR sizes, the Viper guide catheter, and various PTCA guide wires such as the Pursuit Exchange, Controlwire, Entre, Choice PT Plus, and Choice Plus models, some featuring hydrophilic coatings like the ICE coating on 0.014-inch wires.

The company's devices are classified as Class I and Class II medical devices and are listed in the FDA's 510(k) and PMA registries; Scimed Life Systems, Inc. is based in the United States.

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

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Frequently asked questions

How many devices does Scimed Life Systems, Inc. have in the registry?

The registry currently lists 111 devices for Scimed Life Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Scimed Life Systems, Inc.'s devices?

Among its 50 most recently registered devices, Scimed Life Systems, Inc. has devices listed in FDA 510(k) (50 devices).

What risk classes do Scimed Life Systems, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Scimed Life Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Scimed Life Systems, Inc. in the registry?

The most recently registered devices listed for Scimed Life Systems, Inc. include SCIMED TRIGUIDE GUIDE CATHETERS, SCIMED VIPER, SCIMED 7FR AND 8FR TRIGUIDE GUIDING CATHETERS and SCIMED TRIGUIDE GUIDE CATHETER.

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