High Pressure Tubing
K-Number: K244038 · 2025-09-05
Decision Date2025-09-05
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
High Pressure Tubing is a medical device manufactured by Shandong Int Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2025-09-05 under approval 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. It is manufactured by Shandong Int Medical Instruments Co., Ltd.. The 510(k) number is K244038.
When was High Pressure Tubing approved by the FDA?
High Pressure Tubing received FDA 510(k) clearance on 2025-09-05, under approval number K244038.
What company makes High Pressure Tubing?
High Pressure Tubing is manufactured by Shandong Int Medical Instruments Co., Ltd..
What is the FDA product code for High Pressure Tubing?
The FDA product code for High Pressure Tubing is DXT.
Related Clinical Trials
Other Devices by Shandong Int Medical Instruments Co., Ltd.
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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.