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FDA 510(k)

SA-EF MULTI-LUMEN EXTENSION SET

K-Number: K972957 · 1997-09-29

ApplicantVlv Associates, Inc.
Decision Date1997-09-29
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SA-EF MULTI-LUMEN EXTENSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Vlv Associates, Inc.. It received FDA 510(k) clearance on 1997-09-29 under 510(k) number K972957. 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 SA-EF MULTI-LUMEN EXTENSION SET?

SA-EF MULTI-LUMEN EXTENSION SET is a medical device that received FDA 510(k) clearance on 1997-09-29. The listed applicant is Vlv Associates, Inc.. The 510(k) number is K972957.

When did SA-EF MULTI-LUMEN EXTENSION SET receive FDA 510(k) clearance?

SA-EF MULTI-LUMEN EXTENSION SET received FDA 510(k) clearance on 1997-09-29, under 510(k) number K972957.

Who is the listed applicant for SA-EF MULTI-LUMEN EXTENSION SET?

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

What is the FDA product code for SA-EF MULTI-LUMEN EXTENSION SET?

The FDA product code for SA-EF MULTI-LUMEN EXTENSION SET is FPA.

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Other records listing Vlv Associates, 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.

K964876SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SETK955783VLV SA.EF INFUSION PORT EXTENSION SETSK953791VLV SA EF INFUSION PORTK945592VLV SOLODRAW(TM) DUAL CHAMBER PISTON SYRINGEK940406DISPOSABLE, AMBULATORY, INFUSION PUMPSK933364PROMED BIOPSY NEEDLE

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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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