Port, Protector/Cushion

OBK · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5965

Classification

FDA Product Code: OBK
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 880.5965
Review panel: HO
Medical specialty: General Hospital
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Intended to cushion and protect the localized area surrounding the implanted port and indicated for subjects having implanted subcutaneous or intravascular infusion ports.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 0

Source

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