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Implanted Subcutaneous Securement Catheter

FDA product code OKC · 5 cleared devices

Class 2 General Hospital
Regulation
21 CFR 880.5970
Review panel
HO
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2008-09-30 – 2021-04-12

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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