FLUSH DEVICE— 510(k) K833170

Substantially Equivalent

Transamerica Delaval, Inc.

FDA 510(k) clearance K833170 for FLUSH DEVICE, Substantially Equivalent on 1984-08-12. Applicant: Transamerica Delaval, Inc.. Device class: 2.

Clearance details

Applicant
Transamerica Delaval, Inc.
Product code
Code DRS
Device class
Class 2
Regulation
21 CFR 870.2850
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DRS

product code DRS
Death
8
Malfunction
776
Total
784

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.