FDA 510(k)

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System

K-번호: K231549 · 2023-06-29

결정일2023-06-29

제품 코드OTN

자문 위원회SU

결정Substantially Equivalent

기기 요약

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2023-06-29 under 510(k) number K231549. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System?

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System is a medical device that received FDA 510(k) clearance on 2023-06-29. The listed applicant is Boston Scientific Corporation. The 510(k) number is K231549.

When did Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System receive FDA 510(k) clearance?

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System received FDA 510(k) clearance on 2023-06-29, under 510(k) number K231549.

Who is the listed applicant for Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System?

The FDA product code for Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System is OTN.

Boston Scientific Corporation를 신청인으로 등재한 기타 기록

K262151SpaceOAR Flex™ System K261153LithoVue Elite Digital Flexible Ureteroscope System K261915Navigator™ Flex Ureteral Access Sheath Set K262165FARADRIVE™ Steerable Sheath (M004PF21M402)K262462TheraSphere 360™ Y-90 Management Platform K261488OBSIDIO Conformable Embolic

167개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

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