Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Merit Medical System, Inc.. It received FDA 510(k) clearance on 2025-09-10 under approval 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. It is manufactured by Merit Medical System, Inc.. The 510(k) number is K252527.

When was Surfacer Inside-Out Access Catheter System approved by the FDA?

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

What company makes Surfacer Inside-Out Access Catheter System?

Surfacer Inside-Out Access Catheter System is manufactured by Merit Medical System, Inc..

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

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT07610681 Midline Catheter Study ACTIVE_NOT_RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING

Related PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

Other Devices by Merit Medical System, Inc.

K193571Go2Wire Guide Wire K212817Merit Siege Vascular Plug K230636Maestro Microcatheter K231468SCOUT MD Surgical Guidance System

Related Devices (Code: QJH)

DEN190038Surfacer Inside-Out Access Catheter SystemBluegrass Vascular Technologies, Inc.

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.

↑