Cleared Traditional

ULTRA-CBX

K991486 · Medcanica, Inc. · Cardiovascular
Nov 1999
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K991486 is an FDA 510(k) clearance for the ULTRA-CBX, a Device, Biopsy, Endomyocardial (Class II — Special Controls, product code DWZ), submitted by Medcanica, Inc. (Miami, US). The FDA issued a Cleared decision on November 5, 1999, 191 days after receiving the submission on April 28, 1999. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4075.

Submission Details

510(k) Number K991486 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 1999
Decision Date November 05, 1999
Days to Decision 191 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DWZ — Device, Biopsy, Endomyocardial
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4075

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