FDA 510(k)

Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface

K-번호: K170583 · 2017-03-17

결정일2017-03-17

제품 코드DTN

자문 위원회CV

결정Substantially Equivalent

기기 요약

Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2017-03-17 under 510(k) number K170583. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface?

Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface is a medical device that received FDA 510(k) clearance on 2017-03-17. The listed applicant is Medtronic, Inc.. The 510(k) number is K170583.

When did Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface receive FDA 510(k) clearance?

Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface received FDA 510(k) clearance on 2017-03-17, under 510(k) number K170583.

Who is the listed applicant for Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface?

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

What is the FDA product code for Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface?

The FDA product code for Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface is DTN.

Medtronic, Inc.를 신청인으로 등재한 기타 기록

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