Cleared Traditional

MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039

K070705 · Vygon Corp. · General Hospital

Nov 2007

Decision

261d

Days

Class 2

Risk

About This 510(k) Submission

K070705 is an FDA 510(k) clearance for the MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Vygon Corp. (Norristown, US). The FDA issued a Cleared decision on November 30, 2007, 261 days after receiving the submission on March 14, 2007. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K070705 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 2007
Decision Date	November 30, 2007
Days to Decision	261 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