Cleared Traditional

MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE

K013556 · Tyco Healthcare · General Hospital
Dec 2001
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K013556 is an FDA 510(k) clearance for the MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Tyco Healthcare (Mansfield, US). The FDA issued a Cleared decision on December 31, 2001, 67 days after receiving the submission on October 25, 2001. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K013556 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 2001
Decision Date December 31, 2001
Days to Decision 67 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5200

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