CENTRIFUGAL PUMP— 510(k) K011838

Clearance details

Applicant

Stockert Instrumente GmbH

Product code

Code DWA

Device class

Class 2

Regulation

21 CFR 870.4380

Advisory panel

Cardiovascular

Date received

2001-06-12

Decision date

2002-02-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

North Attleboro, MA, US

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• K042374 — STOCKERT SCP RHYTHM2004-09-23
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• K023622 — STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-352002-11-21
• K022280 — STOCKERT CORONARY PERFUSION CANNULAE2002-10-11

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 →

• Z-2439-2020 — Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993Class II·Terminated·LivaNova Deutschland GmbH·20190826
• Z-2440-2020 — Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986Class II·Terminated·LivaNova Deutschland GmbH·20190826
• Z-0166-2013 — SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary bypass circuit for typical durations of six hours or less.Class II·Terminated·Sorin Group USA, Inc.·20120920
• Z-0167-2013 — SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary bypass circuit for typical durations of six hours or less.Class II·Terminated·Sorin Group USA, Inc.·20120920

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K011838.