Home / 510(k) Clearances / K142620

510(k) K142620

0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe by Excelsior Medical Corporation — Product Code NGT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2014
Date Received
September 16, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saline, Vascular Access Flush
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

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

Other clearances by Excelsior Medical Corporation

  • K133446 — HEPARIN LOCK / FLUSH SYRINGES (November 14, 2014)

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