CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100— 510(k) K021694

Name: FDA 510(k) clearance K021694
Creator: U.S. Food and Drug Administration
Published: 2003-01-08

Substantially Equivalent

Cardiovention, Inc.

FDA 510(k) clearance K021694 for CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100, Substantially Equivalent on 2003-01-08. Applicant: Cardiovention, Inc.. Device class: 2.

Clearance details

Applicant: Cardiovention, Inc.
Product code: Code DTQ
Device class: Class 2
Regulation: 21 CFR 870.4220
Advisory panel: Cardiovascular
Date received: 2002-05-22
Decision date: 2003-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DTQ

view all

K232291 — Essenz HLM, Essenz ILBM2023-08-24
K221895 — Terumo Advanced Perfusion System 12023-04-18
K221373 — Essenz HLM2023-03-09
K210130 — Stockert S5 System2021-04-05
K202125 — Century Perfusion System2021-03-07

More clearances from Cardiovention, Inc.

view all

Adverse events under product code DTQ

product code DTQ

Death: 123
Malfunction: 4,822
Other: 1
Total: 4,946

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.