DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS— 510(k) K071427

Substantially Equivalent

Cardiovascular Systems, Inc.

FDA 510(k) clearance K071427 for DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS, Substantially Equivalent on 2007-08-30. Applicant: Cardiovascular Systems, Inc..

Clearance details

Applicant: Cardiovascular Systems, Inc.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2007-05-23
Decision date: 2007-08-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Saint Paul, MN, US

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Adverse events under product code MCW

product code MCW

Death: 38
Injury: 1,386
Malfunction: 2,676
Other: 2
Total: 4,102

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.