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FDA 510(k), K141769, OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER
FDA 510(k), K141769, OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER
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510(K) Number: K141769
Device Name: OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER
Manufacturer: LIGHTLAB IMAGING, INC.
Device Classification Name: catheter, intravascular, diagnostic
Regulation Number: 870.1200
Classification Product Code: DQO
Date Received: 07/01/2014
Decision Date: 08/18/2014
Regulation Medical Specialty: Cardiovascular
Device Name: OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER
Manufacturer: LIGHTLAB IMAGING, INC.
Device Classification Name: catheter, intravascular, diagnostic
Regulation Number: 870.1200
Classification Product Code: DQO
Date Received: 07/01/2014
Decision Date: 08/18/2014
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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