Cleared Special

K990266 - MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE

K990266 · Micromedical Industries, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
5d
Days
-
Risk

K990266 is an FDA 510(k) clearance for the MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE.

Submitted by Micromedical Industries, Ltd. (Northfield, US). The FDA issued a Cleared decision on February 2, 1999 after a review of 5 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.

View all Micromedical Industries, Ltd. devices

FDA 510(k) Submission Details - K990266

510(k) Number K990266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1999
Decision Date February 02, 1999
Days to Decision 5 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
120d faster than avg
Panel avg: 125d · This submission: 5d
Pathway characteristics
Modification to existing cleared device.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

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