Cleared Traditional

BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE

K011967 · Bd · General Hospital
Jan 2002
Decision
212d
Days
Class 2
Risk

About This 510(k) Submission

K011967 is an FDA 510(k) clearance for the BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Bd (Franklin Lakes, US). The FDA issued a Cleared decision on January 23, 2002, 212 days after receiving the submission on June 25, 2001. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K011967 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 2001
Decision Date January 23, 2002
Days to Decision 212 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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