PLEURAL DRAINAGE SYS #PDS-100-4— 510(k) K831849

Name: FDA 510(k) clearance K831849
Creator: U.S. Food and Drug Administration
Published: 1983-12-29

Substantially Equivalent

American Bentley

FDA 510(k) clearance K831849 for PLEURAL DRAINAGE SYS #PDS-100-4, Substantially Equivalent on 1983-12-29. Applicant: American Bentley. Device class: 2.

Clearance details

Applicant: American Bentley
Product code: Code CAC
Device class: Class 2
Regulation: 21 CFR 868.5830
Advisory panel: Anesthesiology
Date received: 1983-06-08
Decision date: 1983-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAC

view all

K241236 — XTRA Collection sets; XTRA Sequestration set X2024-08-16
K240426 — Aventus Clot Management System2024-05-14
K240584 — XTRA Autotransfusion System (with XTRA Bowl sets)2024-04-29
K231782 — FlowSaver Blood Return System (80-101)2023-07-14
K221483 — FlowSaver Blood Return System2023-02-17

More clearances from American Bentley

view all

K872896 — UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-1001988-02-12
K873923 — INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER1987-11-06
K870804 — CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-1001987-09-01
K872167 — CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-35001987-09-01
K872133 — OXYGENATOR MODEL NO. BENTLEY 5 PLUS1987-08-24

Adverse events under product code CAC

product code CAC

Death: 11
Malfunction: 477
Total: 488

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.