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FDA 510(k)

DUAL COMPARTMENT TPN BAG 3 LITER

K-Number: K911567 · 1991-08-02

ApplicantStedim, Inc.
Decision Date1991-08-02
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DUAL COMPARTMENT TPN BAG 3 LITER is the device name listed in this FDA 510(k) record. The listed applicant is Stedim, Inc.. It received FDA 510(k) clearance on 1991-08-02 under 510(k) number K911567. 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 DUAL COMPARTMENT TPN BAG 3 LITER?

DUAL COMPARTMENT TPN BAG 3 LITER is a medical device that received FDA 510(k) clearance on 1991-08-02. The listed applicant is Stedim, Inc.. The 510(k) number is K911567.

When did DUAL COMPARTMENT TPN BAG 3 LITER receive FDA 510(k) clearance?

DUAL COMPARTMENT TPN BAG 3 LITER received FDA 510(k) clearance on 1991-08-02, under 510(k) number K911567.

Who is the listed applicant for DUAL COMPARTMENT TPN BAG 3 LITER?

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

What is the FDA product code for DUAL COMPARTMENT TPN BAG 3 LITER?

The FDA product code for DUAL COMPARTMENT TPN BAG 3 LITER is KPE.

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Other records listing Stedim, 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.

K890204AUTOMIX COMPOUNDER VENTED SPIKE ADAPTORK890205AUTOMIX COMPOUNDER Y - ADAPTOR SET

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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