HEPARIN LOCK / FLUSH SYRINGES— 510(k) K133446

Clearance details

Applicant

Excelsior Medical Corporation

Product code

Code NZW

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

2013-11-12

Decision date

2014-11-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Neptune, NJ, US

• K163591 — BD PosiFlush Heparin Lock Flush Syringe2017-02-27
• K092938 — HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 17102010-06-18
• K092491 — MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES2010-02-03
• K090680 — HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE2009-06-10
• K061497 — SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML2007-02-23

• K142620 — 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe2014-12-12

• Z-1596-2022 — Excelsior Heparin Sodium, Porcine, Preservative Free 100 U / mL Solution Prefilled Syringe, Partial Fill 5 mL Fill in 10 mL Syringe Model Number: 513604Class II·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·20220525

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133446.