MAMBA and MAMBA Flex Microcatheters
FDA 510(k) K190401 · Boston Scientific Corporation
510(k) numberK190401
Submission
- Device name
- MAMBA and MAMBA Flex Microcatheters
- Applicant
- Boston Scientific Corporation
Maple Grove, MN, US - Received
- February 19, 2019
- Decision date
- March 15, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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Questions and answers
When was MAMBA and MAMBA Flex Microcatheters cleared by the FDA?
MAMBA and MAMBA Flex Microcatheters (K190401) received a 510(k) decision of Substantially Equivalent on March 15, 2019, 24 days after the submission was received.
What is the product code of K190401?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.