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FDA 510(k)

Surfacer Inside-Out Access Catheter System

K-Number: K252527 · 2025-09-10

ApplicantMerit Medical System, Inc.
Decision Date2025-09-10
Product CodeQJH
Advisory CommitteeCV
DecisionUnknown

Device Summary

Surfacer Inside-Out Access Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical System, Inc.. It received FDA 510(k) clearance on 2025-09-10 under 510(k) number K252527. The device is classified under product code QJH. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Surfacer Inside-Out Access Catheter System?

Surfacer Inside-Out Access Catheter System is a medical device that received FDA 510(k) clearance on 2025-09-10. The listed applicant is Merit Medical System, Inc.. The 510(k) number is K252527.

When did Surfacer Inside-Out Access Catheter System receive FDA 510(k) clearance?

Surfacer Inside-Out Access Catheter System received FDA 510(k) clearance on 2025-09-10, under 510(k) number K252527.

Who is the listed applicant for Surfacer Inside-Out Access Catheter System?

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

What is the FDA product code for Surfacer Inside-Out Access Catheter System?

The FDA product code for Surfacer Inside-Out Access Catheter System is QJH.

Related Clinical Trials

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.

NCT03101891Renal Anhydramnios Fetal TherapyCOMPLETEDNCT05050799US Post-Market Surveillance Study of the Surfacer SystemRECRUITINGNCT06511999Continuous Jugular Venous Oxygen Saturation (SjO2) Measurement After Cardiac ArrestRECRUITING

Other records listing Merit Medical System, Inc. as applicant

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.

K231468SCOUT MD Surgical Guidance SystemK230636Maestro MicrocatheterK212817Merit Siege Vascular PlugK193571Go2Wire Guide Wire

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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