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Plasco, Inc.

United StatesFDA applicant, unverified

Devices
16

What Plasco, Inc. makes

Plasco, Inc. manufactures respiratory and airway management devices, including CPR micromasks and filters designed for emergency use, as well as oxygen-inlet masks for cardiopulmonary resuscitation. The company also produces enteral feeding sets and related nutrition administration devices, such as the PharmaFeed. Additionally, it supplies incontinence management products like sterile external catheter sets and travel/take-home catheters, along with extension tubing for leg bags. The portfolio further includes contrast media delivery systems, such as the MacBick-XL for barium enema procedures, and a balloon catheter, the Lahr Balloon.

Plasco’s devices are classified under FDA regulations as Class I and Class II, with most products requiring 510(k) clearance. These products are listed in the FDA’s 510(k) registry, reflecting their regulatory status in the United States. The company is headquartered in the US.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue16

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  • Cpr Microshield Ii Ref K950770

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

  • Cpr Micromask With Oxygen Inlet Ref K953414

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

  • Enteral Administration Set Ref K870623

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

  • Pharmafeed Ref K932649

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

  • External Incontinence Catheter Set-Non Ref K832108

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

  • Cpr Micromask Ref K951483

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

  • External Incontinence Catheter Travel Ref K832106

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

  • External Incontinence Catheter Take-Home Ref K832109

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

  • Cpr Filtershield Ref K980066

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

  • Macbick-Xl Basic Air Contast Barium Enema Deliv Sy Ref K870796

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

  • Leg Bag Extention Tube-Sterile Ref K832107

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

  • The Lahr Balloon Ref K870019

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

  • Cpr Micromask Plus Catalog No 73-402 Ref K950769

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

  • Cpr Micromask Ref K943386

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

  • Gastrostomy Feeding Set Ref K831631

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

  • Macbick Disposable Barium Enema Syst 4800 & 4700 Ref K880337

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

Rows 1-16 of 16

Frequently asked questions

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

The registry currently lists 16 devices for Plasco, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Plasco, Inc.'s devices?

Among its 16 most recently registered devices, Plasco, Inc. has devices listed in FDA 510(k) (16 devices).

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

Among its 16 most recently registered devices, the classes recorded for Plasco, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Plasco, Inc. include CPR MICROSHIELD II, CPR MICROMASK WITH OXYGEN INLET, ENTERAL ADMINISTRATION SET and PHARMAFEED.

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