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FDA 510(k)

Distal Access Catheter

K-Number: K233205 · 2023-12-22

ApplicantShanghai Heartcare Medical Technology Co., Ltd.
Decision Date2023-12-22
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Distal Access Catheter is a medical device manufactured by Shanghai Heartcare Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-22 under approval number K233205. 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 Distal Access Catheter?

Distal Access Catheter is a medical device that received FDA 510(k) clearance on 2023-12-22. It is manufactured by Shanghai Heartcare Medical Technology Co., Ltd.. The 510(k) number is K233205.

When was Distal Access Catheter approved by the FDA?

Distal Access Catheter received FDA 510(k) clearance on 2023-12-22, under approval number K233205.

What company makes Distal Access Catheter?

Distal Access Catheter is manufactured by Shanghai Heartcare Medical Technology Co., Ltd..

What is the FDA product code for Distal Access Catheter?

The FDA product code for Distal Access Catheter is QJP.

Related Clinical Trials

NCT07610681 Midline Catheter Study ACTIVE_NOT_RECRUITING NCT07410364 Safety and Efficacy of CAG and PCI Via Distal Transradial Access in Patients With Small Vessels RECRUITING NCT07585188 Neonatal Catheter Lock for Infection Prevention NOT_YET_RECRUITING NCT07512986 Simulation and Video Training for Phlebitis Recognition and Clinical Decision-Making in Nursing Students NOT_YET_RECRUITING NCT04498598 Structural Modification In Supraglottic Airway Device RECRUITING NCT07212855 Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge Protocol COMPLETED

Other Devices by Shanghai Heartcare Medical Technology Co., Ltd.

K202916Balloon Guiding Catheter K202926Micro 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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