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FDA 510(k)

INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE

K-Number: K922382 · 1993-02-05

ApplicantBaxter Healthcare Corp
Decision Date1993-02-05
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1993-02-05 under 510(k) number K922382. The device is classified under product code MEB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE?

INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE is a medical device that received FDA 510(k) clearance on 1993-02-05. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K922382.

When did INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE receive FDA 510(k) clearance?

INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE received FDA 510(k) clearance on 1993-02-05, under 510(k) number K922382.

Who is the listed applicant for INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE?

The FDA product code for INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE is MEB.

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Other records listing Baxter Healthcare Corp as applicant

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Related Devices (Code: MEB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte. , Ltd.K240624InfuLifeFirst Medical Source, LLCK242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte. , Ltd.K181360ON-Q* Pump with BolusHalyard HealthK151650SMARTez elastomeric infusion pumpEpic Medical Pte. , Ltd.K131247MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEMMfs - Medical Flow Systems, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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