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FDA 510(k)

ACUITY Pro Lead Delivery System

K-Number: K171612 · 2017-06-30

ApplicantBoston Scientific Corporation
Decision Date2017-06-30
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACUITY Pro Lead Delivery System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2017-06-30 under approval number K171612. 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 ACUITY Pro Lead Delivery System?

ACUITY Pro Lead Delivery System is a medical device that received FDA 510(k) clearance on 2017-06-30. It is manufactured by Boston Scientific Corporation. The 510(k) number is K171612.

When was ACUITY Pro Lead Delivery System approved by the FDA?

ACUITY Pro Lead Delivery System received FDA 510(k) clearance on 2017-06-30, under approval number K171612.

What company makes ACUITY Pro Lead Delivery System?

ACUITY Pro Lead Delivery System is manufactured by Boston Scientific Corporation.

What is the FDA product code for ACUITY Pro Lead Delivery System?

The FDA product code for ACUITY Pro Lead Delivery System 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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