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FDA 510(k)

Wedge XL Delivery Catheter

K-Number: K232542 · 2024-05-16

ApplicantMicroVention, Inc.
Decision Date2024-05-16
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Wedge XL Delivery Catheter is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2024-05-16 under 510(k) number K232542. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wedge XL Delivery Catheter?

Wedge XL Delivery Catheter is a medical device that received FDA 510(k) clearance on 2024-05-16. The listed applicant is MicroVention, Inc.. The 510(k) number is K232542.

When did Wedge XL Delivery Catheter receive FDA 510(k) clearance?

Wedge XL Delivery Catheter received FDA 510(k) clearance on 2024-05-16, under 510(k) number K232542.

Who is the listed applicant for Wedge XL Delivery Catheter?

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

What is the FDA product code for Wedge XL Delivery Catheter?

The FDA product code for Wedge XL Delivery Catheter is QJP.

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Related Devices (Code: QJP)

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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