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FDA 510(k)

MAMBA and MAMBA Flex Microcatheters

K-Number: K190401 · 2019-03-15

ApplicantBoston Scientific Corporation
Decision Date2019-03-15
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MAMBA and MAMBA Flex Microcatheters is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2019-03-15 under approval number K190401. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAMBA and MAMBA Flex Microcatheters?

MAMBA and MAMBA Flex Microcatheters is a medical device that received FDA 510(k) clearance on 2019-03-15. It is manufactured by Boston Scientific Corporation. The 510(k) number is K190401.

When was MAMBA and MAMBA Flex Microcatheters approved by the FDA?

MAMBA and MAMBA Flex Microcatheters received FDA 510(k) clearance on 2019-03-15, under approval number K190401.

What company makes MAMBA and MAMBA Flex Microcatheters?

MAMBA and MAMBA Flex Microcatheters is manufactured by Boston Scientific Corporation.

What is the FDA product code for MAMBA and MAMBA Flex Microcatheters?

The FDA product code for MAMBA and MAMBA Flex Microcatheters is DQY.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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