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)

MMS PTA Balloon Catheter

K-Number: K152934 · 2016-04-25

ApplicantMicro Medical Solutions, Inc.
Decision Date2016-04-25
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MMS PTA Balloon Catheter is a medical device manufactured by Micro Medical Solutions, Inc.. It received FDA 510(k) clearance on 2016-04-25 under approval number K152934. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MMS PTA Balloon Catheter?

MMS PTA Balloon Catheter is a medical device that received FDA 510(k) clearance on 2016-04-25. It is manufactured by Micro Medical Solutions, Inc.. The 510(k) number is K152934.

When was MMS PTA Balloon Catheter approved by the FDA?

MMS PTA Balloon Catheter received FDA 510(k) clearance on 2016-04-25, under approval number K152934.

What company makes MMS PTA Balloon Catheter?

MMS PTA Balloon Catheter is manufactured by Micro Medical Solutions, Inc..

What is the FDA product code for MMS PTA Balloon Catheter?

The FDA product code for MMS PTA Balloon Catheter is LIT.

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 Micro Medical Solutions, Inc.

K152625MMS Guide Catheter

Related Devices (Code: LIT)

K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K162316Pirouette 014Arravasc, Ltd. K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018Boston Scientific Corporation K161427Pirouette 035Arravasc Limited K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K160004Crosstella OTWKANEKA Corporation

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.

↑