ILUMIEN System with AptiVue Software version D.3
FDA 510(k) K192267 · Abbott Medical
510(k) numberK192267
Submission
- Device name
- ILUMIEN System with AptiVue Software version D.3
- Applicant
- Abbott Medical
Westford, MA, US - Received
- August 21, 2019
- Decision date
- December 17, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 ILUMIEN System with AptiVue Software version D.3 cleared by the FDA?
ILUMIEN System with AptiVue Software version D.3 (K192267) received a 510(k) decision of Substantially Equivalent on December 17, 2019, 118 days after the submission was received.
What is the product code of K192267?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.