PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE— 510(k) K974387

Substantially Equivalent

Microwave Medical Systems, Inc.

FDA 510(k) clearance K974387 for PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE, Substantially Equivalent on 1999-09-01. Applicant: Microwave Medical Systems, Inc..

Clearance details

Applicant: Microwave Medical Systems, Inc.
Product code: Code KDJ
Advisory panel: Gastroenterology, Urology
Date received: 1997-11-21
Decision date: 1999-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Acton, MA, US

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Adverse events under product code KDJ

product code KDJ

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 →

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