BP TRANSDUCER HOLDERS TH-2,3 & 4— 510(k) K832384

Name: FDA 510(k) clearance K832384
Creator: U.S. Food and Drug Administration
Published: 1983-11-14

Substantially Equivalent

American Bentley

FDA 510(k) clearance K832384 for BP TRANSDUCER HOLDERS TH-2,3 & 4, Substantially Equivalent on 1983-11-14. Applicant: American Bentley. Device class: 2.

Clearance details

Applicant: American Bentley
Product code: Code DXO
Device class: Class 2
Regulation: 21 CFR 870.2870
Advisory panel: Cardiovascular
Date received: 1983-07-19
Decision date: 1983-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DXO

view all

K251367 — OptoMonitor 32026-01-16
K241418 — OptoMonitor 32025-02-12
K233904 — ACIST RXi System (016616); ACIST Navvus II Catheter (016675_2024-07-17
K222216 — TruWave Disposable Pressure Transducer2022-12-22
K202943 — OptoMonitor 32020-11-24

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 DXO

product code DXO

Death: 10
Injury: 156
Malfunction: 884
Total: 1,050

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.