← FDA Medical Device Classifications

Saline, Vascular Access Flush

NGT · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5200

Classification

FDA Product Code
NGT
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.5200
Review panel
HO
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Definition

Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.

Market data

Cleared 510(k) submissions
40
Registered establishments
53

Source

Authoritative
FDA Device Classification database
Machine
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