Cleared Special

K023034 - CARDIOTOUCH-3000

K023034 · Bionet Company, Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
63d
Days
-
Risk

K023034 is an FDA 510(k) clearance for the CARDIOTOUCH-3000.

Submitted by Bionet Company, Ltd. (Alpharetta, US). The FDA issued a Cleared decision on November 14, 2002 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K023034

510(k) Number K023034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2002
Decision Date November 14, 2002
Days to Decision 63 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 82
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K023034 · CARDIOTOUCH-3000
Download PDF FDA Summary Bionet Company, Ltd.