BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755— 510(k) K003570

Substantially Equivalent

Bacchus Vascular, Inc.

FDA 510(k) clearance K003570 for BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755, Substantially Equivalent on 2001-06-06. Applicant: Bacchus Vascular, Inc..

Clearance details

Applicant: Bacchus Vascular, Inc.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2000-11-20
Decision date: 2001-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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.