510(k) K190401
K190401 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "MAMBA and MAMBA Flex Microcatheters". The FDA issued a decision of Substantially Equivalent on Mar 15, 2019. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Boston Scientific Corporation has 238 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 15, 2019
- Date Received
- Feb 19, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
- 510(k)