FlexCath Select Steerable Shealth and Dilator - FDA 510(k) K163268

기기 요약

FlexCath Select Steerable Shealth 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 2017-02-02 under 510(k) number K163268. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the FlexCath Select Steerable Shealth and Dilator?

FlexCath Select Steerable Shealth and Dilator is a medical device that received FDA 510(k) clearance on 2017-02-02. The listed applicant is Medtronic Cryocath, LP. The 510(k) number is K163268.

When did FlexCath Select Steerable Shealth and Dilator receive FDA 510(k) clearance?

FlexCath Select Steerable Shealth and Dilator received FDA 510(k) clearance on 2017-02-02, under 510(k) number K163268.

Who is the listed applicant for FlexCath Select Steerable Shealth 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 Select Steerable Shealth and Dilator?

The FDA product code for FlexCath Select Steerable Shealth and Dilator is DYB.

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.

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관련 기기 (코드: DYB)

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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공식 출처

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FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.