CARACELL— 510(k) K953118

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K953118 for CARACELL, Substantially Equivalent on 1996-02-23. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code CAC
Advisory panel: Anesthesiology
Date received: 1995-07-03
Decision date: 1996-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parker, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAC

product code CAC

Death: 11
Malfunction: 477
Total: 488

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.