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FDA 510(k)

LotusCatheter (Lotus No Balloon Catheter)

K-Number: K191512 · 2020-05-21

ApplicantHakki Medical Technologies, Inc.
Decision Date2020-05-21
Product CodeGBM
Advisory CommitteeGU
DecisionUnknown

Device Summary

LotusCatheter (Lotus No Balloon Catheter) is a medical device manufactured by Hakki Medical Technologies, Inc.. It received FDA 510(k) clearance on 2020-05-21 under approval number K191512. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the LotusCatheter (Lotus No Balloon Catheter)?

LotusCatheter (Lotus No Balloon Catheter) is a medical device that received FDA 510(k) clearance on 2020-05-21. It is manufactured by Hakki Medical Technologies, Inc.. The 510(k) number is K191512.

When was LotusCatheter (Lotus No Balloon Catheter) approved by the FDA?

LotusCatheter (Lotus No Balloon Catheter) received FDA 510(k) clearance on 2020-05-21, under approval number K191512.

What company makes LotusCatheter (Lotus No Balloon Catheter)?

LotusCatheter (Lotus No Balloon Catheter) is manufactured by Hakki Medical Technologies, Inc..

What is the FDA product code for LotusCatheter (Lotus No Balloon Catheter)?

The FDA product code for LotusCatheter (Lotus No Balloon Catheter) is GBM.

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

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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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