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FDA 510(k)

Disposable High-pressure Extension Lines

K-Number: K230668 · 2024-06-14

ApplicantPrecision Medical Plastics , Ltd.
Decision Date2024-06-14
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Disposable High-pressure Extension Lines is the device name listed in this FDA 510(k) record. The listed applicant is Precision Medical Plastics , Ltd.. It received FDA 510(k) clearance on 2024-06-14 under 510(k) number K230668. 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 Disposable High-pressure Extension Lines?

Disposable High-pressure Extension Lines is a medical device that received FDA 510(k) clearance on 2024-06-14. The listed applicant is Precision Medical Plastics , Ltd.. The 510(k) number is K230668.

When did Disposable High-pressure Extension Lines receive FDA 510(k) clearance?

Disposable High-pressure Extension Lines received FDA 510(k) clearance on 2024-06-14, under 510(k) number K230668.

Who is the listed applicant for Disposable High-pressure Extension Lines?

The FDA 510(k) record lists Precision Medical Plastics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable High-pressure Extension Lines?

The FDA product code for Disposable High-pressure Extension Lines is DXT.

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

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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