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FDA 510(k)

High Pressure Tubing

K-Number: K244038 · 2025-09-05

ApplicantShandong Int Medical Instruments Co., Ltd.
Decision Date2025-09-05
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

High Pressure Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Int Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2025-09-05 under 510(k) number K244038. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the High Pressure Tubing?

High Pressure Tubing is a medical device that received FDA 510(k) clearance on 2025-09-05. The listed applicant is Shandong Int Medical Instruments Co., Ltd.. The 510(k) number is K244038.

When did High Pressure Tubing receive FDA 510(k) clearance?

High Pressure Tubing received FDA 510(k) clearance on 2025-09-05, under 510(k) number K244038.

Who is the listed applicant for High Pressure Tubing?

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

What is the FDA product code for High Pressure Tubing?

The FDA product code for High Pressure Tubing is DXT.

Other records listing Shandong Int Medical Instruments 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.

K242143Angiography Injector

Related Devices (Code: DXT)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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