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FDA 510(k)

LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE

K-Number: K921674 · 1992-09-23

ApplicantStrato Medical Corp.
Decision Date1992-09-23
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE is the device name listed in this FDA 510(k) record. The listed applicant is Strato Medical Corp.. It received FDA 510(k) clearance on 1992-09-23 under 510(k) number K921674. 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 LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE?

LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE is a medical device that received FDA 510(k) clearance on 1992-09-23. The listed applicant is Strato Medical Corp.. The 510(k) number is K921674.

When did LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE receive FDA 510(k) clearance?

LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE received FDA 510(k) clearance on 1992-09-23, under 510(k) number K921674.

Who is the listed applicant for LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE?

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

What is the FDA product code for LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE?

The FDA product code for LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE is FPA.

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Other records listing Strato Medical Corp. 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.

K945956STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMSK946250STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMSK942848STRATO MEDICAL LIFEPORT LPS 7515K934518STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-KIT PERIPORT PERIPHERAL ACCESS SYSTEMK932509STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORTK933884STRATO MEDICAL LIFEPORT LPS 7255 LOW PROFILE DUAL LUMEN VASCULAR ACCESS SYSTEM

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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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