Decision Date1978-04-21
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
BLOOD FLOWMETER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1978-04-21 under 510(k) number K780302. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BLOOD FLOWMETER SYSTEM?
BLOOD FLOWMETER SYSTEM is a medical device that received FDA 510(k) clearance on 1978-04-21. The listed applicant is Medtronic Vascular. The 510(k) number is K780302.
When did BLOOD FLOWMETER SYSTEM receive FDA 510(k) clearance?
BLOOD FLOWMETER SYSTEM received FDA 510(k) clearance on 1978-04-21, under 510(k) number K780302.
Who is the listed applicant for BLOOD FLOWMETER SYSTEM?
The FDA 510(k) record lists Medtronic Vascular as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BLOOD FLOWMETER SYSTEM?
The FDA product code for BLOOD FLOWMETER SYSTEM is DPW.
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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.