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FDA 510(k)

MAMBA and MAMBA FLEX Microcatheters

K-Number: K171452 · 2017-08-21

ApplicantBoston Scientific Corporation
Decision Date2017-08-21
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MAMBA and MAMBA FLEX Microcatheters is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2017-08-21 under 510(k) number K171452. 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 2017-08-21. The listed applicant is Boston Scientific Corporation. The 510(k) number is K171452.

When did MAMBA and MAMBA FLEX Microcatheters receive FDA 510(k) clearance?

MAMBA and MAMBA FLEX Microcatheters received FDA 510(k) clearance on 2017-08-21, under 510(k) number K171452.

Who is the listed applicant for MAMBA and MAMBA FLEX Microcatheters?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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