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FDA 510(k)

BAG DECANTER

K-Number: K890272 · 1989-03-14

ApplicantSuperior Medical Products
Decision Date1989-03-14
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BAG DECANTER is the device name listed in this FDA 510(k) record. The listed applicant is Superior Medical Products. It received FDA 510(k) clearance on 1989-03-14 under 510(k) number K890272. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAG DECANTER?

BAG DECANTER is a medical device that received FDA 510(k) clearance on 1989-03-14. The listed applicant is Superior Medical Products. The 510(k) number is K890272.

When did BAG DECANTER receive FDA 510(k) clearance?

BAG DECANTER received FDA 510(k) clearance on 1989-03-14, under 510(k) number K890272.

Who is the listed applicant for BAG DECANTER?

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

What is the FDA product code for BAG DECANTER?

The FDA product code for BAG DECANTER is KPE.

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 Superior Medical Products 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.

K863853EAZY COVERS

Related Devices (Code: KPE)

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.

K252079Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.K251980ClaveQS™ BagIcu Medical, Inc.K251139KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AGK252094eZSURE™ Empty Fluid ContainerEpic Medical Pte. , Ltd.K250459DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container SolutionTechnoflex Sas.K241442eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic Medical Pte. , 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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