FDA product code OKC

Implanted Subcutaneous Securement Catheter

General Hospital·Class 2·21 CFR 880.5970·Implantable
US regulatory classifications
US Product Code (FDA)
OKC
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 880.5970
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Medical specialty
General Hospital
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
Definition

Access to central venous system for blood sampling and infusion, and to provide a means to secure the catheter via a subcutaneous anchor below the insertion site.

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Implanted Subcutaneous Securement Catheter is a medical device type in the General Hospital 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.