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FDA 510(k)

ARTERIAL LINE KIT

K-Number: K780871 · 1978-06-14

ApplicantArgon Medical Corp.
Decision Date1978-06-14
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARTERIAL LINE 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 1978-06-14 under 510(k) number K780871. The device is classified under product code GDY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTERIAL LINE KIT?

ARTERIAL LINE KIT is a medical device that received FDA 510(k) clearance on 1978-06-14. The listed applicant is Argon Medical Corp.. The 510(k) number is K780871.

When did ARTERIAL LINE KIT receive FDA 510(k) clearance?

ARTERIAL LINE KIT received FDA 510(k) clearance on 1978-06-14, under 510(k) number K780871.

Who is the listed applicant for ARTERIAL LINE 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 ARTERIAL LINE KIT?

The FDA product code for ARTERIAL LINE KIT is GDY.

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Other records listing Argon Medical Corp. as applicant

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Related Devices (Code: GDY)

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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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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