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FDA 510(k)

ALPHA INFUSION PUMP AND CATHETERS

K-Number: K021964 · 2002-08-12

ApplicantAdvanced Infusion, Inc.
Decision Date2002-08-12
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ALPHA INFUSION PUMP AND CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Infusion, Inc.. It received FDA 510(k) clearance on 2002-08-12 under 510(k) number K021964. 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 ALPHA INFUSION PUMP AND CATHETERS?

ALPHA INFUSION PUMP AND CATHETERS is a medical device that received FDA 510(k) clearance on 2002-08-12. The listed applicant is Advanced Infusion, Inc.. The 510(k) number is K021964.

When did ALPHA INFUSION PUMP AND CATHETERS receive FDA 510(k) clearance?

ALPHA INFUSION PUMP AND CATHETERS received FDA 510(k) clearance on 2002-08-12, under 510(k) number K021964.

Who is the listed applicant for ALPHA INFUSION PUMP AND CATHETERS?

The FDA 510(k) record lists Advanced Infusion, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALPHA INFUSION PUMP AND CATHETERS?

The FDA product code for ALPHA INFUSION PUMP AND CATHETERS is MEB.

Related Clinical Trials

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.

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Other records listing Advanced Infusion, Inc. as applicant

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.

K071532ALPHA INFUSION PUMP, MODEL A200, A450K061661STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20K061356POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6K042246MULTI-DRIP INFUSION CATHETERK992551ALPHA INFUSION PUMP

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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