THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200— 510(k) K092175

Substantially Equivalent

Flowcardia, Inc.

FDA 510(k) clearance K092175 for THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200, Substantially Equivalent on 2010-02-17. Applicant: Flowcardia, Inc..

Clearance details

Applicant: Flowcardia, Inc.
Product code: Code PDU
Advisory panel: Cardiovascular
Date received: 2009-07-21
Decision date: 2010-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
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.