Steerable Guide Catheter— 510(k) K172394

Substantially Equivalent

Abbott Vascular

FDA 510(k) clearance K172394 for Steerable Guide Catheter, Substantially Equivalent on 2017-09-06. Applicant: Abbott Vascular.

Clearance details

Applicant: Abbott Vascular
Product code: Code DRA
Advisory panel: Cardiovascular
Date received: 2017-08-08
Decision date: 2017-09-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRA

product code DRA

Death: 156
Injury: 3,133
Malfunction: 6,266
Total: 9,555

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.