Inspire HCR and HCR DUAL cardiotomy reservoirs— 510(k) K251783

Substantially Equivalent

Sorin Group Italia S.R.L.

FDA 510(k) clearance K251783 for Inspire HCR and HCR DUAL cardiotomy reservoirs, Substantially Equivalent on 2025-12-22. Applicant: Sorin Group Italia S.R.L..

Clearance details

Applicant: Sorin Group Italia S.R.L.
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 2025-06-11
Decision date: 2025-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mirandola (Modena), IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

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.