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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 the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Heartcare Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-08-25 under 510(k) 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. The listed applicant is Shanghai Heartcare Medical Technology Co., Ltd.. The 510(k) number is K202916.

When did Balloon Guiding Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Balloon Guiding Catheter?

The FDA 510(k) record lists Shanghai Heartcare Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Balloon Guiding Catheter?

The FDA product code for Balloon Guiding Catheter is QJP.

Other records listing Shanghai Heartcare Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233205Distal Access CatheterK202926Micro Catheter

Related Devices (Code: QJP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260199SLIM MicrocatheterBalt USA, LLCK253901Millipede88 Access CatheterPerfuze, Ltd.K261889Trevo Trak 21 MicrocatheterStryker NeurovascularK261808ISAAC Neurovascular Navigation CatheterMicrovention Inc. d/b/a Terumo NeuroK261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo NeuroK253359Zenith Distal Access Long SheathSuzhou Zenith Vascular SciTech 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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