EXACTECH(TM)— 510(k) K863468

Name: FDA 510(k) clearance K863468
Creator: U.S. Food and Drug Administration
Published: 1986-12-08

Substantially Equivalent

Travenol Laboratories, S.A.

FDA 510(k) clearance K863468 for EXACTECH(TM), Substantially Equivalent on 1986-12-08. Applicant: Travenol Laboratories, S.A.. Device class: 2.

Clearance details

Applicant: Travenol Laboratories, S.A.
Product code: Code CGA
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 1986-09-08
Decision date: 1986-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deerfield, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CGA

view all

K252488 — ABL90 FLEX PLUS System2026-05-01
K210933 — YSI 2900C Biochemistry Analyzer2024-09-30
K220328 — EasyStat 3002024-07-26
K223179 — Cholestech LDX System2023-09-20
K223755 — i-STAT G cartridge with the i-STAT 1 System2023-09-11

More clearances from Travenol Laboratories, S.A.

view all

K874181 — BAXTER BEDSIDE SYSTEM1988-02-22
K873894 — CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE1987-11-05
K873873 — RESUBMITTED MICRON TRANSFUSION FILTER1987-10-22
K873984 — AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)1987-10-20
K872364 — HEMODIALYSIS (SPS), MODEL 550, CODE 5M13091987-10-13

Adverse events under product code CGA

product code CGA

Death: 2
Malfunction: 1,816
Total: 1,818

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.