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FDA 510(k)

CHARTERMED TPN-EVA BAGS

K-Number: K973103 · 1997-11-24

ApplicantChartermed, Inc.
Decision Date1997-11-24
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CHARTERMED TPN-EVA BAGS is the device name listed in this FDA 510(k) record. The listed applicant is Chartermed, Inc.. It received FDA 510(k) clearance on 1997-11-24 under 510(k) number K973103. 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 CHARTERMED TPN-EVA BAGS?

CHARTERMED TPN-EVA BAGS is a medical device that received FDA 510(k) clearance on 1997-11-24. The listed applicant is Chartermed, Inc.. The 510(k) number is K973103.

When did CHARTERMED TPN-EVA BAGS receive FDA 510(k) clearance?

CHARTERMED TPN-EVA BAGS received FDA 510(k) clearance on 1997-11-24, under 510(k) number K973103.

Who is the listed applicant for CHARTERMED TPN-EVA BAGS?

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

What is the FDA product code for CHARTERMED TPN-EVA BAGS?

The FDA product code for CHARTERMED TPN-EVA BAGS 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.

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 Chartermed, 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.

K902079ADMIXTURE CONTAINER FOR TOTAL PARENTERAL NUTRITIONK902464CHARTERMED EMPTY TPN CONTAINER - 100 ML CAPACITYK901753600 OR 1200 ML. ENTERAL BAG ADMINISTRATION 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

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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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