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FDA 510(k)

SET FOR ASEPTIC DECANTING OF A FLEX I.V

K-Number: K812852 · 1981-11-02

ApplicantDip, Inc.
Decision Date1981-11-02
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SET FOR ASEPTIC DECANTING OF A FLEX I.V is the device name listed in this FDA 510(k) record. The listed applicant is Dip, Inc.. It received FDA 510(k) clearance on 1981-11-02 under 510(k) number K812852. 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 SET FOR ASEPTIC DECANTING OF A FLEX I.V?

SET FOR ASEPTIC DECANTING OF A FLEX I.V is a medical device that received FDA 510(k) clearance on 1981-11-02. The listed applicant is Dip, Inc.. The 510(k) number is K812852.

When did SET FOR ASEPTIC DECANTING OF A FLEX I.V receive FDA 510(k) clearance?

SET FOR ASEPTIC DECANTING OF A FLEX I.V received FDA 510(k) clearance on 1981-11-02, under 510(k) number K812852.

Who is the listed applicant for SET FOR ASEPTIC DECANTING OF A FLEX I.V?

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

What is the FDA product code for SET FOR ASEPTIC DECANTING OF A FLEX I.V?

The FDA product code for SET FOR ASEPTIC DECANTING OF A FLEX I.V 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 Dip, 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.

K813019PERCUTANEOUS INTRODUCER: SELDINGER STYLEK812973PERCUTANEOUS INTRODUCER COURNAND STYLE

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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