FDA 510(k)

Single-use Sterile High-pressure Angiographic Syringes and Accessories

K-Number: K241109 · 2024-08-22

ApplicantShenzhen Boon Medical Supply Co., Ltd.

Decision Date2024-08-22

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Single-use Sterile High-pressure Angiographic Syringes and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Boon Medical Supply Co., Ltd.. It received FDA 510(k) clearance on 2024-08-22 under 510(k) number K241109. 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 Single-use Sterile High-pressure Angiographic Syringes and Accessories?

Single-use Sterile High-pressure Angiographic Syringes and Accessories is a medical device that received FDA 510(k) clearance on 2024-08-22. The listed applicant is Shenzhen Boon Medical Supply Co., Ltd.. The 510(k) number is K241109.

When did Single-use Sterile High-pressure Angiographic Syringes and Accessories receive FDA 510(k) clearance?

Single-use Sterile High-pressure Angiographic Syringes and Accessories received FDA 510(k) clearance on 2024-08-22, under 510(k) number K241109.

Who is the listed applicant for Single-use Sterile High-pressure Angiographic Syringes and Accessories?

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

What is the FDA product code for Single-use Sterile High-pressure Angiographic Syringes and Accessories?

The FDA product code for Single-use Sterile High-pressure Angiographic Syringes and Accessories is DXT.

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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.