VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900— 510(k) K071660

Substantially Equivalent

Volcano Corporation

FDA 510(k) clearance K071660 for VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900, Substantially Equivalent on 2007-08-31. Applicant: Volcano Corporation.

Clearance details

Applicant: Volcano Corporation
Product code: Code OBJ
Advisory panel: Cardiovascular
Date received: 2007-06-18
Decision date: 2007-08-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Rancho Cordova,, CA, US

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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.