Implanted Subcutaneous Securement Catheter

OKC · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5970

Classification

FDA Product Code: OKC
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 880.5970
Review panel: HO
Medical specialty: General Hospital
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 5
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown