Cleared Traditional

MODIFICATION TO ACS CORONARY GUIDING

K841992 · Advanced Cardiovascular Systems, Inc. · Immunology
Jun 1984
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K841992 is an FDA 510(k) clearance for the MODIFICATION TO ACS CORONARY GUIDING, a Igm (mu Chain Specific), Antigen, Antiserum, Control (Class II — Special Controls, product code DAO), submitted by Advanced Cardiovascular Systems, Inc. (Santa Clara, US). The FDA issued a Cleared decision on June 11, 1984, 47 days after receiving the submission on April 25, 1984. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K841992 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 1984
Decision Date June 11, 1984
Days to Decision 47 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DAO — Igm (mu Chain Specific), Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5550

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