Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use

NQJ · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5540

Classification

FDA Product Code: NQJ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.5540
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: Y
Implant: N
Third-party review: N

Definition

Dual lumen, non-implanted, peripheral access catheters are inserted in the peripheral arm vein and are indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.

Market data

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

Source

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