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FDA 510(k)

Firefighter™ Pro PTCA Balloon Catheter

K-Number: K252116 · 2026-04-07

ApplicantShanghai MicroPort Medical (Group) Co., Ltd.
Decision Date2026-04-07
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Firefighter™ Pro PTCA Balloon Catheter is a medical device manufactured by Shanghai MicroPort Medical (Group) Co., Ltd.. It received FDA 510(k) clearance on 2026-04-07 under approval number K252116. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Firefighter™ Pro PTCA Balloon Catheter?

Firefighter™ Pro PTCA Balloon Catheter is a medical device that received FDA 510(k) clearance on 2026-04-07. It is manufactured by Shanghai MicroPort Medical (Group) Co., Ltd.. The 510(k) number is K252116.

When was Firefighter™ Pro PTCA Balloon Catheter approved by the FDA?

Firefighter™ Pro PTCA Balloon Catheter received FDA 510(k) clearance on 2026-04-07, under approval number K252116.

What company makes Firefighter™ Pro PTCA Balloon Catheter?

Firefighter™ Pro PTCA Balloon Catheter is manufactured by Shanghai MicroPort Medical (Group) Co., Ltd..

What is the FDA product code for Firefighter™ Pro PTCA Balloon Catheter?

The FDA product code for Firefighter™ Pro PTCA Balloon Catheter is LOX.

Related Clinical Trials

NCT04647253 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) ACTIVE_NOT_RECRUITING NCT06492174 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort ACTIVE_NOT_RECRUITING NCT07214948 Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction NOT_YET_RECRUITING NCT07414771 Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP) NOT_YET_RECRUITING NCT07587541 Low-VOLTage Area-Guided Catheter Ablation and SVC Isolation for Persistent Atrial Fibrillation Using a Balloon-in-Basket Pulsed Field Ablation Catheter NOT_YET_RECRUITING NCT07583706 A Single-center, Single-arm Study to Evaluate the Safety and Efficacy of Ultra-minimally Invasive Prostate Dilation in Treating Patients With Significant Obstructive Symptoms Caused by Benign Prostatic Hyperplasia RECRUITING

Other Devices by Shanghai MicroPort Medical (Group) Co., Ltd.

K223189Firefighter™ NC Pro PTCA Balloon Catheter

Related Devices (Code: LOX)

K163200Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation CatheteBoston Scientific Corporation K163174Emerge PTCA Dilatation CatheterBoston Scientific Corporation K160985Pantera ProBiotronik, Inc. K162209Sapphire NC PlusOrbusneich Medical, Inc. K153742Apollo Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K160961Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited

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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