HERO VASCULAR ACCESS DEVICE— 510(k) K091491

Substantially Equivalent

Hemosphere, Inc.

FDA 510(k) clearance K091491 for HERO VASCULAR ACCESS DEVICE, Substantially Equivalent on 2009-07-31. Applicant: Hemosphere, Inc..

Clearance details

Applicant: Hemosphere, Inc.
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 2009-05-20
Decision date: 2009-07-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Eden Prarie, MN, US

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Adverse events under product code DSY

product code DSY

Death: 29
Injury: 694
Total: 723

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.