ACUTE PERITONEAL DIALYSIS CATHETERS— 510(k) K854966

Substantially Equivalent

Thermedics, Inc.

FDA 510(k) clearance K854966 for ACUTE PERITONEAL DIALYSIS CATHETERS, Substantially Equivalent on 1986-01-09. Applicant: Thermedics, Inc..

Clearance details

Applicant: Thermedics, Inc.
Product code: Code FKO
Advisory panel: Gastroenterology, Urology
Date received: 1985-12-11
Decision date: 1986-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

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Adverse events under product code FKO

product code FKO

Other: 1
Total: 1

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.