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FDA 510(k)

VERSASAE PLASTIC CANNULA- 11 GAUGE

K-Number: K945070 · 1995-01-13

ApplicantImed Corp.
Decision Date1995-01-13
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VERSASAE PLASTIC CANNULA- 11 GAUGE is the device name listed in this FDA 510(k) record. The listed applicant is Imed Corp.. It received FDA 510(k) clearance on 1995-01-13 under 510(k) number K945070. 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 VERSASAE PLASTIC CANNULA- 11 GAUGE?

VERSASAE PLASTIC CANNULA- 11 GAUGE is a medical device that received FDA 510(k) clearance on 1995-01-13. The listed applicant is Imed Corp.. The 510(k) number is K945070.

When did VERSASAE PLASTIC CANNULA- 11 GAUGE receive FDA 510(k) clearance?

VERSASAE PLASTIC CANNULA- 11 GAUGE received FDA 510(k) clearance on 1995-01-13, under 510(k) number K945070.

Who is the listed applicant for VERSASAE PLASTIC CANNULA- 11 GAUGE?

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

What is the FDA product code for VERSASAE PLASTIC CANNULA- 11 GAUGE?

The FDA product code for VERSASAE PLASTIC CANNULA- 11 GAUGE is FPA.

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Other records listing Imed 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.

K960512GEMINI PC-ITXK953896THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETSK950153VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVESK951922ADMINISTRATION SETS WITH BALL FLOATK950419THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETSK944320VENTED/NON-VENTED GEMINI ADMINISTRATION SET

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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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