SwiftNINJA Microcatheter
FDA 510(k) K161921 · Merit Medical Systems, Inc.
510(k) numberK161921
Submission
- Device name
- SwiftNINJA Microcatheter
- Applicant
- Merit Medical Systems, Inc.
South Jordan, UT, US - Received
- July 13, 2016
- Decision date
- November 4, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRA – Catheter, Continuous Flush
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1210
- Specialty
- Cardiovascular
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Questions and answers
When was SwiftNINJA Microcatheter cleared by the FDA?
SwiftNINJA Microcatheter (K161921) received a 510(k) decision of Substantially Equivalent on November 4, 2016, 114 days after the submission was received.
What is the product code of K161921?
The FDA product code is KRA – Catheter, Continuous Flush, a Class II (moderate risk) device regulated under 21 CFR 870.1210.