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FDA 510(k)

Shadow Catheter

K-Number: K240885 · 2024-12-19

ApplicantSimpson Interventions, Inc.
Decision Date2024-12-19
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Shadow Catheter is a medical device manufactured by Simpson Interventions, Inc.. It received FDA 510(k) clearance on 2024-12-19 under approval number K240885. 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 Shadow Catheter?

Shadow Catheter is a medical device that received FDA 510(k) clearance on 2024-12-19. It is manufactured by Simpson Interventions, Inc.. The 510(k) number is K240885.

When was Shadow Catheter approved by the FDA?

Shadow Catheter received FDA 510(k) clearance on 2024-12-19, under approval number K240885.

What company makes Shadow Catheter?

Shadow Catheter is manufactured by Simpson Interventions, Inc..

What is the FDA product code for Shadow Catheter?

The FDA product code for Shadow 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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