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FDA 510(k)

Superpipe Angiographic Catheter

K-Number: K193647 · 2020-07-29

ApplicantSuzhou Hengrui Disheng Medical Co., Ltd.
Decision Date2020-07-29
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Superpipe Angiographic Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Hengrui Disheng Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-07-29 under 510(k) number K193647. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Superpipe Angiographic Catheter?

Superpipe Angiographic Catheter is a medical device that received FDA 510(k) clearance on 2020-07-29. The listed applicant is Suzhou Hengrui Disheng Medical Co., Ltd.. The 510(k) number is K193647.

When did Superpipe Angiographic Catheter receive FDA 510(k) clearance?

Superpipe Angiographic Catheter received FDA 510(k) clearance on 2020-07-29, under 510(k) number K193647.

Who is the listed applicant for Superpipe Angiographic Catheter?

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

What is the FDA product code for Superpipe Angiographic Catheter?

The FDA product code for Superpipe Angiographic Catheter is DQO.

Other records listing Suzhou Hengrui Disheng Medical Co., Ltd. as applicant

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Related Devices (Code: DQO)

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.

K261455Arterial Pressure Monitoring Set/TraySpectrum VascularK252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum VascularK250751DualView CatheterTerumo CorporationK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, Ltd.

Official Source

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