FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100— 510(k) K090621

Substantially Equivalent

Flowcardia, Inc.

FDA 510(k) clearance K090621 for FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100, Substantially Equivalent on 2009-06-19. Applicant: Flowcardia, Inc..

Clearance details

Applicant: Flowcardia, Inc.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 2009-03-09
Decision date: 2009-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.