Tunneled Catheter Remover

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

Classification

FDA Product Code: ODY
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: N
Third-party review: N

Definition

To assist in the removal of tunneled long term catheter cuffs using a minimal invasive technique by seperating the tissue ingrowth cuff from the surrounding tissue. Following seperation of the cuff from the tissue, the catheter can be safely removed from the body.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 9

Source

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