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FDA 510(k)

EXTENSION SET WITH CHECK VALVE

K-Number: K954983 · 1996-01-23

ApplicantDistronic Sterile Products, Inc.
Decision Date1996-01-23
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EXTENSION SET WITH CHECK VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Distronic Sterile Products, Inc.. It received FDA 510(k) clearance on 1996-01-23 under 510(k) number K954983. 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 EXTENSION SET WITH CHECK VALVE?

EXTENSION SET WITH CHECK VALVE is a medical device that received FDA 510(k) clearance on 1996-01-23. The listed applicant is Distronic Sterile Products, Inc.. The 510(k) number is K954983.

When did EXTENSION SET WITH CHECK VALVE receive FDA 510(k) clearance?

EXTENSION SET WITH CHECK VALVE received FDA 510(k) clearance on 1996-01-23, under 510(k) number K954983.

Who is the listed applicant for EXTENSION SET WITH CHECK VALVE?

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

What is the FDA product code for EXTENSION SET WITH CHECK VALVE?

The FDA product code for EXTENSION SET WITH CHECK VALVE is FPA.

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Other records listing Distronic Sterile Products, 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.

K955709WINGED & SUBCUTANEOUS INFUSION SETSK955732VENTED SOLUTION SETK954984MINIBORE STOPCOCK SETK952664SOLUTION ADMINISTRATION SETK950597CORE-RESISTANT HUBER INFUSION SET WITH Y-SITEK95266360 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP

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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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