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FDA 510(k)

Balloon Guiding Catheter

K-Number: K202916 · 2021-08-25

ApplicantShanghai Heartcare Medical Technology Co., Ltd.
Decision Date2021-08-25
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Balloon Guiding Catheter is a medical device manufactured by Shanghai Heartcare Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-08-25 under approval number K202916. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Balloon Guiding Catheter?

Balloon Guiding Catheter is a medical device that received FDA 510(k) clearance on 2021-08-25. It is manufactured by Shanghai Heartcare Medical Technology Co., Ltd.. The 510(k) number is K202916.

When was Balloon Guiding Catheter approved by the FDA?

Balloon Guiding Catheter received FDA 510(k) clearance on 2021-08-25, under approval number K202916.

What company makes Balloon Guiding Catheter?

Balloon Guiding Catheter is manufactured by Shanghai Heartcare Medical Technology Co., Ltd..

What is the FDA product code for Balloon Guiding Catheter?

The FDA product code for Balloon Guiding Catheter is QJP.

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 Heartcare Medical Technology Co., Ltd.

K202926Micro Catheter K233205Distal Access Catheter

Related Devices (Code: QJP)

K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc. K201682RIST Radial Access CatheterRist Neurovascular, Inc. K201518Route 92 Medical 088 Access SystemRoute 92 Medical K201076Anchor Dual Lumen Guidewire CatheterAqure Medical, Inc. K200910BOSS Balloon Guide CatheterMarblehead Medical K200417RIST Radial Access CatheterRist Neurovascular, 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.

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