BLOOD PUMP MODEL 7000— 510(k) K780942

Substantially Equivalent

3M Health Care, Sarns

FDA 510(k) clearance K780942 for BLOOD PUMP MODEL 7000, Substantially Equivalent on 1978-06-19. Applicant: 3M Health Care, Sarns. Device class: 2.

Clearance details

Applicant
3M Health Care, Sarns
Product code
Code DWB
Device class
Class 2
Regulation
21 CFR 870.4370
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DWB

product code DWB
Death
2
Total
2

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.