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FDA 510(k)

CENTRAL CATHETER KIT

K-Number: K780673 · 1978-05-16

ApplicantArgon Medical Corp.
Decision Date1978-05-16
Product CodeFPK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CENTRAL CATHETER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Argon Medical Corp.. It received FDA 510(k) clearance on 1978-05-16 under 510(k) number K780673. The device is classified under product code FPK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTRAL CATHETER KIT?

CENTRAL CATHETER KIT is a medical device that received FDA 510(k) clearance on 1978-05-16. The listed applicant is Argon Medical Corp.. The 510(k) number is K780673.

When did CENTRAL CATHETER KIT receive FDA 510(k) clearance?

CENTRAL CATHETER KIT received FDA 510(k) clearance on 1978-05-16, under 510(k) number K780673.

Who is the listed applicant for CENTRAL CATHETER KIT?

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

What is the FDA product code for CENTRAL CATHETER KIT?

The FDA product code for CENTRAL CATHETER KIT is FPK.

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Other records listing Argon 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.

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Related Devices (Code: FPK)

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.

K131517MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBINGMedrad, Inc. / Bayer Medical Care, Inc.K063114DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVESCoeur, Inc.K063239LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526Hospira, Inc.K052431MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1Medtronic MinimedK041178EMPOWER TRANSFER SET, (CAT. NO. 7725)E-Z-Em, Inc.K031808MEDRAD SWABBABLE VALVE TRANSFER SETMedrad, Inc.

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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