VAC-RITE— 510(k) K770649

Substantially Equivalent

Medical Development Co.

FDA 510(k) clearance K770649 for VAC-RITE, Substantially Equivalent on 1977-06-02. Applicant: Medical Development Co.. Device class: 2.

Clearance details

Applicant
Medical Development Co.
Product code
Code KDQ
Device class
Class 2
Regulation
21 CFR 880.6740
Advisory panel
General Hospital
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 KDQ

product code KDQ
Death
8
Malfunction
637
Total
645

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.