MODIFICATION TO THE CROSSER SYSTEM— 510(k) K091119

Substantially Equivalent

Flowcardia, Inc.

FDA 510(k) clearance K091119 for MODIFICATION TO THE CROSSER SYSTEM, Substantially Equivalent on 2009-05-15. Applicant: Flowcardia, Inc..

Clearance details

Applicant: Flowcardia, Inc.
Product code: Code PDU
Advisory panel: Cardiovascular
Date received: 2009-04-17
Decision date: 2009-05-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

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Adverse events under product code PDU

product code PDU

Malfunction: 793
Total: 793

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.