FDA 510(k)

JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire

K-Number: K180795 · 2018-04-12

Decision Date2018-04-12

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2018-04-12 under 510(k) number K180795. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire?

JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire is a medical device that received FDA 510(k) clearance on 2018-04-12. The listed applicant is Boston Scientific. The 510(k) number is K180795.

When did JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire receive FDA 510(k) clearance?

JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire received FDA 510(k) clearance on 2018-04-12, under 510(k) number K180795.

Who is the listed applicant for JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire?

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

What is the FDA product code for JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire?

The FDA product code for JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire is DQX.

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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.