FDA 510(k)

DiscCath Needle Set

K-번호: K212328 · 2021-09-26

결정일2021-09-26

제품 코드BSP

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기기 요약

DiscCath Needle Set is the device name listed in this FDA 510(k) record. The listed applicant is Disccath, LLC. It received FDA 510(k) clearance on 2021-09-26 under 510(k) number K212328. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the DiscCath Needle Set?

DiscCath Needle Set is a medical device that received FDA 510(k) clearance on 2021-09-26. The listed applicant is Disccath, LLC. The 510(k) number is K212328.

When did DiscCath Needle Set receive FDA 510(k) clearance?

DiscCath Needle Set received FDA 510(k) clearance on 2021-09-26, under 510(k) number K212328.

Who is the listed applicant for DiscCath Needle Set?

The FDA 510(k) record lists Disccath, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DiscCath Needle Set?

The FDA product code for DiscCath Needle Set is BSP.

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DiscCath Needle Set

기기 요약

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관련 임상시험

관련 기기 (코드: BSP)

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