DIDECO PEDIATRIC ARTERIAL FILTERS— 510(k) K945198

Substantially Equivalent

Sorin Biomedical, Inc.

FDA 510(k) clearance K945198 for DIDECO PEDIATRIC ARTERIAL FILTERS, Substantially Equivalent on 1995-06-27. Applicant: Sorin Biomedical, Inc..

Clearance details

Applicant: Sorin Biomedical, Inc.
Product code: Code DTM
Advisory panel: Cardiovascular
Date received: 1994-10-24
Decision date: 1995-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.