Cleared Traditional

MANIFOLD

K972654 · Medical Specialties Intl., Inc. · Cardiovascular

Oct 1997

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K972654 is an FDA 510(k) clearance for the MANIFOLD, a Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (Class II — Special Controls, product code DTL), submitted by Medical Specialties Intl., Inc. (Tarpon Springs, US). The FDA issued a Cleared decision on October 8, 1997, 85 days after receiving the submission on July 15, 1997. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4290.

Submission Details

510(k) Number	K972654 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 1997
Decision Date	October 08, 1997
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement

Device Classification

Product Code	DTL — Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.4290