MODIFICATION TO THE CROSSER SYSTEM— 510(k) K091119

Name: FDA 510(k) clearance K091119
Creator: U.S. Food and Drug Administration
Published: 2009-05-15

Substantially Equivalent

Flowcardia, Inc.

FDA 510(k) clearance K091119 for MODIFICATION TO THE CROSSER SYSTEM, Substantially Equivalent on 2009-05-15. Applicant: Flowcardia, Inc.. Device class: 2.

Clearance details

Applicant: Flowcardia, Inc.
Product code: Code PDU
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2009-04-17
Decision date: 2009-05-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Flowcardia, Inc.

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K092175 — THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN2002010-02-17
K090621 — FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 1002009-06-19
K091254 — THE CROSSER 14 OTW CATHETER, MODEL CRU0142009-05-29
K080849 — MICROSHEATH LP AND LP-AT2008-07-25
K080765 — CROSSER LP SYSTEM2008-06-20

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.