COMBOMAP PRESSURE AND FLOW SYSTEM— 510(k) K041134

Substantially Equivalent

Volcano Therapeutics, Inc.

FDA 510(k) clearance K041134 for COMBOMAP PRESSURE AND FLOW SYSTEM, Substantially Equivalent on 2004-06-02. Applicant: Volcano Therapeutics, Inc..

Clearance details

Applicant: Volcano Therapeutics, Inc.
Product code: Code OBJ
Advisory panel: Cardiovascular
Date received: 2004-04-30
Decision date: 2004-06-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Rancho Cordova,, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OBJ

product code OBJ

Death: 38
Injury: 634
Malfunction: 3,453
Total: 4,125

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.