TRACER— 510(k) K982617

Substantially Equivalent

Heartland Medical Systems, Inc.

FDA 510(k) clearance K982617 for TRACER, Substantially Equivalent on 1999-04-09. Applicant: Heartland Medical Systems, Inc..

Clearance details

Applicant: Heartland Medical Systems, Inc.
Product code: Code MWJ
Advisory panel: Cardiovascular
Date received: 1998-07-27
Decision date: 1999-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newbury Park, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWJ

product code MWJ

Other: 1
Total: 1

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.