HeartLight Deflectable Sheath— 510(k) K152310

Substantially Equivalent

Cardiofocus, Inc.

FDA 510(k) clearance K152310 for HeartLight Deflectable Sheath, Substantially Equivalent on 2016-02-24. Applicant: Cardiofocus, Inc..

Clearance details

Applicant: Cardiofocus, Inc.
Product code: Code DRA
Advisory panel: Cardiovascular
Date received: 2015-08-14
Decision date: 2016-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, 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.