FDA product code QLZ
Septostomy Catheter, Reprocessed
Cardiovascular·Class 2·21 CFR 870.5175
US regulatory classifications
- US Product Code (FDA)
- QLZView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 870.5175View CFR Regulation →
- Medical specialty
- Cardiovascular
Device characteristics
- GMP exempt
- Yes
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
To create or enlarge an atrial septal defect in the heart.
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About this record
Septostomy Catheter, Reprocessed is a medical device type in the Cardiovascular 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.
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.