E-VAX CHEST DRAINAGE SYSTEM— 510(k) K801043

Name: FDA 510(k) clearance K801043
Creator: U.S. Food and Drug Administration
Published: 1980-06-20

Substantially Equivalent

Cardio Surgical Concepts, Inc.

FDA 510(k) clearance K801043 for E-VAX CHEST DRAINAGE SYSTEM, Substantially Equivalent on 1980-06-20. Applicant: Cardio Surgical Concepts, Inc.. Device class: 2.

Clearance details

Applicant: Cardio Surgical Concepts, Inc.
Product code: Code JCX
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 1980-05-05
Decision date: 1980-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JCX

view all

K250964 — Protable Phlegm Suction Unit (JMA D01)2026-05-11
K243638 — MV Flow Aspiration Pump (MVFLOWPMP01)2025-06-13
K251111 — Cary2025-05-07
K243418 — Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing2024-12-02
K233428 — Easycess Aspiration Pump2023-11-03

Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.