Trevo Trak 21 Microcatheter
FDA 510(k) K192122 · Stryker
510(k) numberK192122
Submission
- Device name
- Trevo Trak 21 Microcatheter
- Applicant
- Stryker
Fremont, CA, US - Received
- August 6, 2019
- Decision date
- November 22, 2019
- 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 Trevo Trak 21 Microcatheter cleared by the FDA?
Trevo Trak 21 Microcatheter (K192122) received a 510(k) decision of Substantially Equivalent on November 22, 2019, 108 days after the submission was received.
What is the product code of K192122?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.