AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101— 510(k) K020693

Substantially Equivalent

Embol-X, Inc.

FDA 510(k) clearance K020693 for AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101, Substantially Equivalent on 2002-09-05. Applicant: Embol-X, Inc..

Clearance details

Applicant: Embol-X, Inc.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2002-03-04
Decision date: 2002-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

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Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.