iNtuition-Structural Heart Module— 510(k) K191585

Substantially Equivalent

Terarecon,Inc.

FDA 510(k) clearance K191585 for iNtuition-Structural Heart Module, Substantially Equivalent on 2019-07-12. Applicant: Terarecon,Inc..

Clearance details

Applicant: Terarecon,Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2019-06-14
Decision date: 2019-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foster City, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.