Blood Flowmeter System
FDA 510(k) K780302 · Medtronic Vascular
510(k) numberK780302
Submission
- Device name
- Blood Flowmeter System
- Applicant
- Medtronic Vascular
Walker, MI, US - Received
- February 22, 1978
- Decision date
- April 21, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
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Questions and answers
When was Blood Flowmeter System cleared by the FDA?
Blood Flowmeter System (K780302) received a 510(k) decision of Substantially Equivalent on April 21, 1978, 58 days after the submission was received.
What is the product code of K780302?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.