FDA 510(k)

Sterile High-pressure Angiographic Syringes for Single-use

K-Number: K182289 · 2018-10-10

ApplicantShenzhen Baoan Medical Supplies Co., Ltd.

Decision Date2018-10-10

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Sterile High-pressure Angiographic Syringes for Single-use is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Baoan Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2018-10-10 under 510(k) number K182289. 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 Sterile High-pressure Angiographic Syringes for Single-use?

Sterile High-pressure Angiographic Syringes for Single-use is a medical device that received FDA 510(k) clearance on 2018-10-10. The listed applicant is Shenzhen Baoan Medical Supplies Co., Ltd.. The 510(k) number is K182289.

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

Sterile High-pressure Angiographic Syringes for Single-use received FDA 510(k) clearance on 2018-10-10, under 510(k) number K182289.

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

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

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

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

Other records listing Shenzhen Baoan Medical Supplies 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.

K151960Sterile High-pressure Angiographic Syringes for Single-use

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Official Source

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