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FDA 510(k)

Reverse 021 Micro Catheter, Reverse 027 Micro Catheter

K-Number: K171268 · 2017-05-31

ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Decision Date2017-05-31
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reverse 021 Micro Catheter, Reverse 027 Micro Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2017-05-31 under 510(k) number K171268. 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 Reverse 021 Micro Catheter, Reverse 027 Micro Catheter?

Reverse 021 Micro Catheter, Reverse 027 Micro Catheter is a medical device that received FDA 510(k) clearance on 2017-05-31. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K171268.

When did Reverse 021 Micro Catheter, Reverse 027 Micro Catheter receive FDA 510(k) clearance?

Reverse 021 Micro Catheter, Reverse 027 Micro Catheter received FDA 510(k) clearance on 2017-05-31, under 510(k) number K171268.

Who is the listed applicant for Reverse 021 Micro Catheter, Reverse 027 Micro Catheter?

The FDA 510(k) record lists Micro Therapeutics, Inc. d/b/a ev3 Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reverse 021 Micro Catheter, Reverse 027 Micro Catheter?

The FDA product code for Reverse 021 Micro Catheter, Reverse 027 Micro 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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