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510(k) K101270

SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311 by Excelsior Medical Corp. — Product Code NGT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2011
Date Received
May 6, 2010
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 Corp.

  • K130975 — SWABCAP AND SWABFLUSH (December 24, 2013)
  • 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)
  • 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 NGT

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  • K233623 — Praxiject™ SP 0.9% NaCl (February 27, 2024)
  • K231724 — Flush Syringe (Prefilled 0.9% normal saline solution) (November 9, 2023)
  • K231363 — Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, (September 27, 2023)
  • K223584 — Pre-Filled Normal Saline Flush Syringe (August 12, 2023)
  • K230756 — TK Pre-Filled Normal Saline Flush Syringe (August 12, 2023)
  • K231161 — 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe (July 21, 2023)
  • K231754 — Praxiject™ 0.9% NaCl (July 13, 2023)
  • K214080 — Pentaflush (July 20, 2022)
  • K220060 — Pre-filled Syringe with Saline (June 10, 2022)