SwiftNINJA Steerable Microcatheter
FDA 510(k) K211525 · Merit Medical Systems, Inc.
510(k) numberK211525
Submission
- Device name
- SwiftNINJA Steerable Microcatheter
- Applicant
- Merit Medical Systems, Inc.
South Jordan, UT, US - Received
- May 17, 2021
- Decision date
- July 16, 2021
- 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 Steerable Microcatheter cleared by the FDA?
SwiftNINJA Steerable Microcatheter (K211525) received a 510(k) decision of Substantially Equivalent on July 16, 2021, 60 days after the submission was received.
What is the product code of K211525?
The FDA product code is KRA – Catheter, Continuous Flush, a Class II (moderate risk) device regulated under 21 CFR 870.1210.