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FDA 510(k)

SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET

K-Number: K963355 · 1996-10-04

ApplicantSolopak Medical Products, Inc.
Decision Date1996-10-04
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Solopak Medical Products, Inc.. It received FDA 510(k) clearance on 1996-10-04 under 510(k) number K963355. 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 SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET?

SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET is a medical device that received FDA 510(k) clearance on 1996-10-04. The listed applicant is Solopak Medical Products, Inc.. The 510(k) number is K963355.

When did SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET receive FDA 510(k) clearance?

SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET received FDA 510(k) clearance on 1996-10-04, under 510(k) number K963355.

Who is the listed applicant for SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET?

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

What is the FDA product code for SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET?

The FDA product code for SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Solopak Medical Products, 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.

K970800MAXCESS NEEDLEFREE - Y- SITE (100713)K962663SOLOPAK SIDEKICK INFUSION PUMP AND ADMINISTATION SETK960661MAXCESS NEEDLE FREE CONNECTOR (8200)

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

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

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