FlexCath Advance Steerable Sheath and Dilator - FDA 510(k) K202620

기기 요약

FlexCath Advance Steerable Sheath and Dilator is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Cryocath, LP. It received FDA 510(k) clearance on 2020-11-13 under 510(k) number K202620. The device is classified under product code DRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the FlexCath Advance Steerable Sheath and Dilator?

FlexCath Advance Steerable Sheath and Dilator is a medical device that received FDA 510(k) clearance on 2020-11-13. The listed applicant is Medtronic Cryocath, LP. The 510(k) number is K202620.

When did FlexCath Advance Steerable Sheath and Dilator receive FDA 510(k) clearance?

FlexCath Advance Steerable Sheath and Dilator received FDA 510(k) clearance on 2020-11-13, under 510(k) number K202620.

Who is the listed applicant for FlexCath Advance Steerable Sheath and Dilator?

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

What is the FDA product code for FlexCath Advance Steerable Sheath and Dilator?

The FDA product code for FlexCath Advance Steerable Sheath and Dilator is DRA.

Medtronic Cryocath, LP를 신청인으로 등재한 기타 기록

관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.

K183174FlexCath Advance Steerable Sheath and Dilator K163268FlexCath Select Steerable Shealth and Dilator

관련 기기 (코드: DRA)

관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.

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