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FDA 510(k)

LO-PROFILE EXTENSIONSET W/ .22 MICRON FILTER

K-Number: K925430 · 1993-08-03

ApplicantDouglas Medical Products Corp.
Decision Date1993-08-03
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LO-PROFILE EXTENSIONSET W/ .22 MICRON FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Douglas Medical Products Corp.. It received FDA 510(k) clearance on 1993-08-03 under 510(k) number K925430. 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 LO-PROFILE EXTENSIONSET W/ .22 MICRON FILTER?

LO-PROFILE EXTENSIONSET W/ .22 MICRON FILTER is a medical device that received FDA 510(k) clearance on 1993-08-03. The listed applicant is Douglas Medical Products Corp.. The 510(k) number is K925430.

When did LO-PROFILE EXTENSIONSET W/ .22 MICRON FILTER receive FDA 510(k) clearance?

LO-PROFILE EXTENSIONSET W/ .22 MICRON FILTER received FDA 510(k) clearance on 1993-08-03, under 510(k) number K925430.

Who is the listed applicant for LO-PROFILE EXTENSIONSET W/ .22 MICRON FILTER?

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

What is the FDA product code for LO-PROFILE EXTENSIONSET W/ .22 MICRON FILTER?

The FDA product code for LO-PROFILE EXTENSIONSET W/ .22 MICRON FILTER is FPA.

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Other records listing Douglas Medical Products 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.

K961155SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908K954428SOLOPICC 24 (60CM) 20GA CATHETERK94162840 MICRON BLOOD TRANSFUSION FILTERK9421014-LEAD IRRIGATION SETK941453CHECK VALVE SOLUTION SETK930854SOLUTION SET WITH .2 MICRON FILTER

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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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