FUKUDA DENSHI CARDIMAX FK-11— 510(k) K813023

Name: FDA 510(k) clearance K813023
Creator: U.S. Food and Drug Administration
Published: 1981-12-02

Substantially Equivalent

Brentwood Instruments, Inc.

FDA 510(k) clearance K813023 for FUKUDA DENSHI CARDIMAX FK-11, Substantially Equivalent on 1981-12-02. Applicant: Brentwood Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Brentwood Instruments, Inc.
Product code: Code DSP
Device class: Class 2
Regulation: 21 CFR 870.3535
Advisory panel: Cardiovascular
Date received: 1981-10-27
Decision date: 1981-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DSP

view all

K250542 — AC3 Range Intra-Aortic Balloon Pump2025-03-26
K232343 — AC3 Series IABP2023-08-30
K201112 — AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP2020-05-27
K200634 — Arrow FiberOptix Intra-Aortic Balloon Catheter Kit2020-04-09
K192238 — AC3 Series Intra-Aortic Balloon Pump (IABP)2019-11-12

More clearances from Brentwood Instruments, Inc.

view all

K896924 — SPIROSCAN 40001990-03-01
K882366 — RHYTHMSCAN HR HOLTER RECORDER1988-08-02
K871572 — RHYTHMSCAN1988-02-22
K860024 — FUKUDA DENSHI CARDIMAX FCP-2111986-03-31
K853979 — CARDIMAX FX-11641986-02-06

Adverse events under product code DSP

product code DSP

Death: 317
Injury: 566
Malfunction: 36,831
Other: 4
Total: 37,718

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.