PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8— 510(k) K860155

Clearance details

Applicant

Medical Components, Inc.

Product code

Code FKO

Device class

Class 2

Regulation

21 CFR 876.5630

Advisory panel

Gastroenterology, Urology

Date received

1986-01-16

Decision date

1986-02-14

Decision

Unknown

Clearance type

Traditional

Location

Harleysville, PA, US

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• K885037 — AMUKIN 50% - AIRSPRAY(R)1990-10-19
• K874650 — PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)1987-12-09

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• K130687 — 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER2013-08-15

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 →