← FDA Medical Device Classifications

Heparin, Vascular Access Flush

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

Classification

FDA Product Code
NZW
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
7
Registered establishments
7

Source

Authoritative
FDA Device Classification database
Machine
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