Cleared Traditional

TERUMO SURFLASH SAFETY I.V. CATHETER

K122544 · Terumo Corporation · General Hospital

Sep 2012

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K122544 is an FDA 510(k) clearance for the TERUMO SURFLASH SAFETY I.V. CATHETER, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Terumo Corporation (Yamanashi, JP). The FDA issued a Cleared decision on September 5, 2012, 15 days after receiving the submission on August 21, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K122544 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 21, 2012
Decision Date	September 05, 2012
Days to Decision	15 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