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FDA 510(k)

DELTA-FLOW

K-Number: K780479 · 1978-11-22

Decision Date1978-11-22
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DELTA-FLOW is the device name listed in this FDA 510(k) record. The listed applicant is Tri-Delta Intl.. It received FDA 510(k) clearance on 1978-11-22 under 510(k) number K780479. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DELTA-FLOW?

DELTA-FLOW is a medical device that received FDA 510(k) clearance on 1978-11-22. The listed applicant is Tri-Delta Intl.. The 510(k) number is K780479.

When did DELTA-FLOW receive FDA 510(k) clearance?

DELTA-FLOW received FDA 510(k) clearance on 1978-11-22, under 510(k) number K780479.

Who is the listed applicant for DELTA-FLOW?

The FDA 510(k) record lists Tri-Delta Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DELTA-FLOW?

The FDA product code for DELTA-FLOW is KRA.

Related Clinical Trials

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.

Related Devices (Code: KRA)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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