Cleared Traditional

PACEVIEW

K915627 · Micromedical Industries, Ltd. · Cardiovascular
Mar 1992
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K915627 is an FDA 510(k) clearance for the PACEVIEW, a Probe, Thermodilution (Class II — Special Controls, product code KRB), submitted by Micromedical Industries, Ltd. (Northbrook, US). The FDA issued a Cleared decision on March 27, 1992, 109 days after receiving the submission on December 9, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1915.

Submission Details

510(k) Number K915627 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 1991
Decision Date March 27, 1992
Days to Decision 109 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code KRB — Probe, Thermodilution
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1915

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