ACUTE PERITONEAL DIALYSIS CATHETERS— 510(k) K854966

Name: FDA 510(k) clearance K854966
Creator: U.S. Food and Drug Administration
Published: 1986-01-09

Substantially Equivalent

Thermedics, Inc.

FDA 510(k) clearance K854966 for ACUTE PERITONEAL DIALYSIS CATHETERS, Substantially Equivalent on 1986-01-09. Applicant: Thermedics, Inc.. Device class: 2.

Clearance details

Applicant: Thermedics, Inc.
Product code: Code FKO
Device class: Class 2
Regulation: 21 CFR 876.5630
Advisory panel: Gastroenterology, Urology
Date received: 1985-12-11
Decision date: 1986-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FKO

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K964514 — CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS1998-06-26
K974570 — PERITONEAL DIALYSIS CATHETER CONNECTOR1998-02-27
K910787 — TITANIUM CONNECTOR (2 PART)1991-08-15
K885037 — AMUKIN 50% - AIRSPRAY(R)1990-10-19
K874650 — PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)1987-12-09

More clearances from Thermedics, Inc.

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K894131 — DERMAPORT VASCULAR ACCESS DEVICE MODEL NO. 50-10001989-09-26
K863128 — PERITONEAL DIALYSIS CATHETERS1986-09-09
K850076 — WOUND DRESSING MODEL ZB-61985-04-15

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.