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FDA 510(k)

NEEDLE-FREE VALVED CONNECTOR AND CAP

K-Number: K964439 · 1997-07-16

ApplicantBmw Medical, Inc.
Decision Date1997-07-16
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEEDLE-FREE VALVED CONNECTOR AND CAP is the device name listed in this FDA 510(k) record. The listed applicant is Bmw Medical, Inc.. It received FDA 510(k) clearance on 1997-07-16 under 510(k) number K964439. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEEDLE-FREE VALVED CONNECTOR AND CAP?

NEEDLE-FREE VALVED CONNECTOR AND CAP is a medical device that received FDA 510(k) clearance on 1997-07-16. The listed applicant is Bmw Medical, Inc.. The 510(k) number is K964439.

When did NEEDLE-FREE VALVED CONNECTOR AND CAP receive FDA 510(k) clearance?

NEEDLE-FREE VALVED CONNECTOR AND CAP received FDA 510(k) clearance on 1997-07-16, under 510(k) number K964439.

Who is the listed applicant for NEEDLE-FREE VALVED CONNECTOR AND CAP?

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

What is the FDA product code for NEEDLE-FREE VALVED CONNECTOR AND CAP?

The FDA product code for NEEDLE-FREE VALVED CONNECTOR AND CAP is FPA.

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Other records listing Bmw Medical, 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.

K963806CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T)K963215CLAMPLESS VALVED CATHETER - MIDLINE (CVC-ML)K963097CLAMPLESS VALVED CATHETER-PICC (CVC-PICC)K962300CLAMPLESS VALVED CATHETER

Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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