Home / 510(k) Clearances / K061497

510(k) K061497

SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML by Excelsior Medical Corp. — Product Code NZW

K061497 is an FDA 510(k) premarket notification submitted by Excelsior Medical Corp. for the device "SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML". The FDA issued a decision of Substantially Equivalent on February 23, 2007. 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
February 23, 2007
Date Received
May 31, 2006
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)
  • K053120 — STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES (December 9, 2005)
  • K023740 — SYREX PRE-FILLED SYRINGE (May 13, 2003)
  • 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)
  • K023740 — SYREX PRE-FILLED SYRINGE (May 13, 2003)

FDA data resources