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FDA 510(k)

CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE

K-Number: K950597 · 1995-07-26

ApplicantDistronic Sterile Products, Inc.
Decision Date1995-07-26
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE 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 1995-07-26 under 510(k) number K950597. 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 CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE?

CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE is a medical device that received FDA 510(k) clearance on 1995-07-26. The listed applicant is Distronic Sterile Products, Inc.. The 510(k) number is K950597.

When did CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE receive FDA 510(k) clearance?

CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE received FDA 510(k) clearance on 1995-07-26, under 510(k) number K950597.

Who is the listed applicant for CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE?

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 CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE?

The FDA product code for CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE 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 SETK954983EXTENSION SET WITH CHECK VALVEK952664SOLUTION ADMINISTRATION SETK95266360 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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