Cleared Traditional

MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE

K032438 · Tyco Healthcare · General Hospital

Jun 2004

Decision

328d

Days

Class 2

Risk

About This 510(k) Submission

K032438 is an FDA 510(k) clearance for the MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE, a Saline, Vascular Access Flush (Class II — Special Controls, product code NGT), submitted by Tyco Healthcare (Mansfield, US). The FDA issued a Cleared decision on June 30, 2004, 328 days after receiving the submission on August 7, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K032438 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 07, 2003
Decision Date	June 30, 2004
Days to Decision	328 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	NGT — Saline, Vascular Access Flush
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200
Definition	Enhance The Performance Of Intravascular Catheters, To Maintain Patency Of The Vascular Catheter When It Is Not In Use.