FDA 510(k)

OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT

K-Number: K844854 · 1985-05-21

Decision Date1985-05-21

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT is the device name listed in this FDA 510(k) record. The listed applicant is Vas-Cath of Canada , Ltd.. It received FDA 510(k) clearance on 1985-05-21 under 510(k) number K844854. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT?

OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT is a medical device that received FDA 510(k) clearance on 1985-05-21. The listed applicant is Vas-Cath of Canada , Ltd.. The 510(k) number is K844854.

When did OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT receive FDA 510(k) clearance?

OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT received FDA 510(k) clearance on 1985-05-21, under 510(k) number K844854.

Who is the listed applicant for OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT?

The FDA 510(k) record lists Vas-Cath of Canada , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT?

The FDA product code for OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT is DQO.

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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.