FDA 510(k)

SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller

K-Number: K200483 · 2020-05-21

Decision Date2020-05-21

Product CodeFBN

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2020-05-21 under approval number K200483. The device is classified under product code FBN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller?

SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller is a medical device that received FDA 510(k) clearance on 2020-05-21. It is manufactured by Boston Scientific Corporation. The 510(k) number is K200483.

When was SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller approved by the FDA?

SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller received FDA 510(k) clearance on 2020-05-21, under approval number K200483.

What company makes SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller?

SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller is manufactured by Boston Scientific Corporation.

What is the FDA product code for SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller?

The FDA product code for SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller is FBN.

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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.