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FDA 510(k)

ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD

K-Number: K843261 · 1984-09-11

ApplicantAngiosystems, Inc.
Decision Date1984-09-11
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD is the device name listed in this FDA 510(k) record. The listed applicant is Angiosystems, Inc.. It received FDA 510(k) clearance on 1984-09-11 under 510(k) number K843261. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD?

ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD is a medical device that received FDA 510(k) clearance on 1984-09-11. The listed applicant is Angiosystems, Inc.. The 510(k) number is K843261.

When did ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD receive FDA 510(k) clearance?

ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD received FDA 510(k) clearance on 1984-09-11, under 510(k) number K843261.

Who is the listed applicant for ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD?

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

What is the FDA product code for ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD?

The FDA product code for ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD is DRE.

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Related Devices (Code: DRE)

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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