STARCLOSE HEX-HUB DILATOR— 510(k) K062554

Substantially Equivalent

Abbott Vascular, Inc.

FDA 510(k) clearance K062554 for STARCLOSE HEX-HUB DILATOR, Substantially Equivalent on 2007-02-06. Applicant: Abbott Vascular, Inc..

Clearance details

Applicant: Abbott Vascular, Inc.
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 2006-08-30
Decision date: 2007-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRE

product code DRE

Death: 100
Injury: 832
Malfunction: 597
Other: 3
Total: 1,532

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.