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510(k) K023740

SYREX PRE-FILLED SYRINGE by Excelsior Medical Corp. — Product Code NZW

K023740 is an FDA 510(k) premarket notification submitted by Excelsior Medical Corp. for the device "SYREX PRE-FILLED SYRINGE". The FDA issued a decision of Substantially Equivalent on May 13, 2003. The device falls under product code NZW (Heparin, Vascular Access Flush), a Class II device regulated under 21 CFR 880.5200. Excelsior Medical Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2003
Date Received
November 7, 2002
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 Corp.

  • K130975 — SWABCAP AND SWABFLUSH (December 24, 2013)
  • K101270 — SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311 (February 10, 2011)
  • K083508 — SWABCAP (April 28, 2009)
  • K082837 — STERILE FIELD SALINE PRE-FILLED SYRINGE(S) (December 18, 2008)
  • K061497 — SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML (February 23, 2007)
  • K053120 — STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES (December 9, 2005)
  • K962938 — EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE) (October 25, 1996)
  • K942349 — MICROBORE EXTENSION SET (February 8, 1995)

Other clearances for product code NZW

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

FDA data resources