OSTIAL PRO STENT POSITIONING SYSTEM— 510(k) K062192

Substantially Equivalent

Ostial Solutions, LLC

FDA 510(k) clearance K062192 for OSTIAL PRO STENT POSITIONING SYSTEM, Substantially Equivalent on 2007-05-24. Applicant: Ostial Solutions, LLC.

Clearance details

Applicant: Ostial Solutions, LLC
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2006-07-31
Decision date: 2007-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

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.