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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 the device name listed in this FDA 510(k) record. The listed applicant is Simpson Interventions, Inc.. It received FDA 510(k) clearance on 2024-12-19 under 510(k) 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. The listed applicant is Simpson Interventions, Inc.. The 510(k) number is K240885.

When did Shadow Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Shadow Catheter?

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

What is the FDA product code for Shadow Catheter?

The FDA product code for Shadow Catheter is DQY.

Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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