STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP— 510(k) K032213

Name: FDA 510(k) clearance K032213
Creator: U.S. Food and Drug Administration
Published: 2003-08-29

Substantially Equivalent

Stockert Instrumente GmbH

FDA 510(k) clearance K032213 for STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP, Substantially Equivalent on 2003-08-29. Applicant: Stockert Instrumente GmbH. Device class: 2.

Clearance details

Applicant: Stockert Instrumente GmbH
Product code: Code DWA
Device class: Class 2
Regulation: 21 CFR 870.4380
Advisory panel: Cardiovascular
Date received: 2003-07-21
Decision date: 2003-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWA

view all

More clearances from Stockert Instrumente GmbH

view all

K042374 — STOCKERT SCP RHYTHM2004-09-23
K041558 — STOCKERTIR PURGE CONTROL (APC) SYSTEM2004-07-02
K023622 — STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-352002-11-21
K022280 — STOCKERT CORONARY PERFUSION CANNULAE2002-10-11
K022321 — STOCKERT V172-28 VENOUS FEMORAL CANNULA2002-10-09

Adverse events under product code DWA

product code DWA

Death: 15
Malfunction: 1,654
Total: 1,669

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.