MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES— 510(k) K092491

Clearance details

Applicant

Medefil, Inc.

Product code

Code NZW

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

2009-08-13

Decision date

2010-02-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Glendale Heights, IL, US

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• K121262 — MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY2012-09-20
• K091583 — MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE2010-01-28
• K020996 — MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL2002-06-24
• K020999 — MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL2002-06-20
• K993518 — MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE LL2000-06-12

• Z-1149-2014 — Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.Class III·Terminated·Medefil Incorporated·20140219

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K092491.