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510(k) K082837

STERILE FIELD SALINE PRE-FILLED SYRINGE(S) by Excelsior Medical Corp. — Product Code NGT

K082837 is an FDA 510(k) premarket notification submitted by Excelsior Medical Corp. for the device "STERILE FIELD SALINE PRE-FILLED SYRINGE(S)". The FDA issued a decision of Substantially Equivalent on December 18, 2008. The device falls under product code NGT (Saline, 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
December 18, 2008
Date Received
September 26, 2008
Clearance Type
Special
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)
  • K101270 — SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311 (February 10, 2011)
  • K083508 — SWABCAP (April 28, 2009)
  • 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

  • K250884 — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe (December 2, 2025)
  • 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)
  • K213522 — AMSafe Pre-Filled Normal Saline Flush Syringe (March 22, 2022)

FDA data resources