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 LL— 510(k) K020996

Clearance details

Applicant

Medefil, Inc.

Product code

Code NGT

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

2002-03-28

Decision date

2002-06-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Schaumburg, IL, US

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• K121262 — MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY2012-09-20
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• K091583 — MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE2010-01-28
• 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

Death

12

Malfunction

2,008

Other

4

Total

2,024

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →