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510(k) K133446

HEPARIN LOCK / FLUSH SYRINGES by Excelsior Medical Corporation — Product Code NZW

K133446 is an FDA 510(k) premarket notification submitted by Excelsior Medical Corporation for the device "HEPARIN LOCK / FLUSH SYRINGES". The FDA issued a decision of Substantially Equivalent on November 14, 2014. The device falls under product code NZW (Heparin, Vascular Access Flush), a Class II device regulated under 21 CFR 880.5200. Excelsior Medical Corporation has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2014
Date Received
November 12, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heparin, 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

  • K142620 — 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chlori (December 12, 2014)

Other clearances for product code NZW

  • K163591 — BD PosiFlush Heparin Lock Flush Syringe (February 27, 2017)
  • K092938 — HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, (June 18, 2010)
  • K092491 — MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN (February 3, 2010)
  • K090680 — HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE (June 10, 2009)
  • K061497 — SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML (February 23, 2007)
  • K023740 — SYREX PRE-FILLED SYRINGE (May 13, 2003)

FDA data resources