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FDA 510(k)

ISAAC Neurovascular Navigation Catheter

K-Number: K222115 · 2023-01-10

ApplicantMicroVention, Inc.
Decision Date2023-01-10
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ISAAC Neurovascular Navigation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2023-01-10 under 510(k) number K222115. 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 ISAAC Neurovascular Navigation Catheter?

ISAAC Neurovascular Navigation Catheter is a medical device that received FDA 510(k) clearance on 2023-01-10. The listed applicant is MicroVention, Inc.. The 510(k) number is K222115.

When did ISAAC Neurovascular Navigation Catheter receive FDA 510(k) clearance?

ISAAC Neurovascular Navigation Catheter received FDA 510(k) clearance on 2023-01-10, under 510(k) number K222115.

Who is the listed applicant for ISAAC Neurovascular Navigation Catheter?

The FDA 510(k) record lists MicroVention, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISAAC Neurovascular Navigation Catheter?

The FDA product code for ISAAC Neurovascular Navigation Catheter 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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