CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER— 510(k) K132474

Name: FDA 510(k) clearance K132474
Creator: U.S. Food and Drug Administration
Published: 2014-01-30

Substantially Equivalent

Acist Medical Systems

FDA 510(k) clearance K132474 for CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER, Substantially Equivalent on 2014-01-30. Applicant: Acist Medical Systems. Device class: 2.

Clearance details

Applicant: Acist Medical Systems
Product code: Code DXO
Device class: Class 2
Regulation: 21 CFR 870.2870
Advisory panel: Cardiovascular
Date received: 2013-08-07
Decision date: 2014-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, 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 Acist Medical Systems

view all

K020892 — ACIST GENTOO CONTRAST INJECTION SYSTEM2003-01-27
K021015 — ACIST PLUS 4 ANGIOGRAPHIC CATHETER2002-04-26
K991103 — MODIFICATION TO ACIST CL 100H2000-05-31
K000013 — ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-20002000-03-28
K993774 — ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH1999-12-07

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.