PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES— 510(k) K900295

Clearance details

Applicant

Microwave Medical Systems, Inc.

Product code

Code KDJ

Device class

Class 2

Regulation

21 CFR 876.5630

Advisory panel

Gastroenterology, Urology

Date received

1990-01-22

Decision date

1990-11-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Littleton, MA, US

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Death

298

Injury

9,221

Malfunction

8,438

Other

1

Total

17,958

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →