MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST— 510(k) K100789

Substantially Equivalent

Evalve, Inc.

FDA 510(k) clearance K100789 for MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST, Substantially Equivalent on 2010-04-21. Applicant: Evalve, Inc..

Clearance details

Applicant: Evalve, Inc.
Product code: Code DRA
Advisory panel: Cardiovascular
Date received: 2010-03-22
Decision date: 2010-04-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Menlo Park, CA, US

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Adverse events under product code DRA

product code DRA

Death: 156
Injury: 3,133
Malfunction: 6,266
Total: 9,555

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.