FDA product code OBD

Barrier, Adhesion, Cardiovascular

Unknown·Class 3·21 CFR ·Implantable
US regulatory classifications
US Product Code (FDA)
OBD
View Product Code Classification →
US Risk Class (FDA)
Class 3
US Regulation (CFR)
21 CFR
View CFR Regulation →
Medical specialty
Unknown
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
Definition

Indicated to reduce the incidence, severity or extent of adhesions/tissue attachment in cardiovascular surgery by providing a plane of dissection or mechanical barrier between opposing surfaces of tissue and/or devices. Intended for use in cardiac surgery to prevent or reduce adhesions, and facilitate reoperation in patients who are anticipated to need staged cardiovascular surgeries or repeat procedures in the thoracic region.

Search keywords
About this record

Barrier, Adhesion, Cardiovascular is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.