MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456— 510(k) K041727

Substantially Equivalent

Boston Scientific Scimed, Inc.

FDA 510(k) clearance K041727 for MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456, Substantially Equivalent on 2004-07-23. Applicant: Boston Scientific Scimed, Inc..

Clearance details

Applicant: Boston Scientific Scimed, Inc.
Product code: Code OBJ
Advisory panel: Cardiovascular
Date received: 2004-06-25
Decision date: 2004-07-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, 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.