FDA product code PNE
Reprocessed Catheter Introducer
Cardiovascular·Class 2·21 CFR 870.1340
US regulatory classifications
- US Product Code (FDA)
- PNEView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 870.1340View CFR Regulation →
- Medical specialty
- Cardiovascular
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
Introduce various cardiovascular catheters into the heart and cardiovascular system
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About this record
Reprocessed Catheter Introducer 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.