Optis Integrated System, Dragonfly Optis Imaging Catheter
FDA 510(k) K141769 · Lightlab Imaging, Inc.
510(k) numberK141769
Submission
- Device name
- Optis Integrated System, Dragonfly Optis Imaging Catheter
- Applicant
- Lightlab Imaging, Inc.
Westford, MA, US - Received
- July 1, 2014
- Decision date
- August 18, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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Questions and answers
When was Optis Integrated System, Dragonfly Optis Imaging Catheter cleared by the FDA?
Optis Integrated System, Dragonfly Optis Imaging Catheter (K141769) received a 510(k) decision of Substantially Equivalent on August 18, 2014, 48 days after the submission was received.
What is the product code of K141769?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.