Cleared Traditional

K931729 - I.V. START KIT
(FDA 510(k) Clearance)

K931729 · Carapace, Inc. · General Hospital

Feb 1994

Decision

321d

Days

Class 2

Risk

K931729 is an FDA 510(k) clearance for the I.V. START KIT. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ).

Submitted by Carapace, Inc. (Broken Arrow, US). The FDA issued a Cleared decision on February 22, 1994, 321 days after receiving the submission on April 7, 1993.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K931729 FDA.gov
FDA Decision	Cleared SEKD
Date Received	April 07, 1993
Decision Date	February 22, 1994
Days to Decision	321 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

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