ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP— 510(k) K894255

Substantially Equivalent

St. Jude Medical, Inc.

FDA 510(k) clearance K894255 for ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP, Substantially Equivalent on 1989-09-26. Applicant: St. Jude Medical, Inc..

Clearance details

Applicant: St. Jude Medical, Inc.
Product code: Code KFM
Advisory panel: Cardiovascular
Date received: 1989-06-20
Decision date: 1989-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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Adverse events under product code KFM

product code KFM

Death: 109
Injury: 241
Malfunction: 1,779
Total: 2,129

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.