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FDA product code OKC

Implanted Subcutaneous Securement Catheter

General HospitalClass 221 CFR 880.5970Implantable
Verified
US regulatory classifications
US Product Code (FDA)
OKC
View Product Code Classification
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 880.5970
View CFR Regulation
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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01Implanted catheter02Securement catheter03Subcutaneous catheter04Anchoring catheter05Implantable line06Catheter securement07SC catheter08Long-term catheter09Fixed catheter10Tunneled catheter
About this record

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.