Subcutaneous Implanted Apheresis Port

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

Classification

FDA Product Code: PTD
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: Y
Third-party review: N

Definition

A subcutaneous implanted apheresis port is a prescription device intended for patient therapies requiring repeated access to the vascular system and long-term therapeutic apheresis

Market data

Cleared 510(k) submissions: 3
Registered establishments: 4

Source

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