Home / 510(k) Clearances / K092938

510(k) K092938

HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 by App Pharmaceuticals, LLC — Product Code NZW

K092938 is an FDA 510(k) premarket notification submitted by App Pharmaceuticals, LLC for the device "HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710". The FDA issued a decision of Substantially Equivalent on June 18, 2010. The device falls under product code NZW (Heparin, Vascular Access Flush), a Class II device regulated under 21 CFR 880.5200.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2010
Date Received
September 24, 2009
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 for product code NZW

  • K163591 — BD PosiFlush Heparin Lock Flush Syringe (February 27, 2017)
  • K133446 — HEPARIN LOCK / FLUSH SYRINGES (November 14, 2014)
  • 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