STOCKERT SCP RHYTHM— 510(k) K042374

Name: FDA 510(k) clearance K042374
Creator: U.S. Food and Drug Administration
Published: 2004-09-23

Substantially Equivalent

Stockert Instrumente GmbH

FDA 510(k) clearance K042374 for STOCKERT SCP RHYTHM, Substantially Equivalent on 2004-09-23. 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: 2004-09-01
Decision date: 2004-09-23
Decision: Substantially Equivalent
Clearance type: Special
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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K041558 — STOCKERTIR PURGE CONTROL (APC) SYSTEM2004-07-02
K032213 — STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP2003-08-29
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.