FDA 510(k)

Sapphire ULTRA Coronary Dilatation Catheter

K-번호: K233505 · 2024-08-15

신청자OrbusNeich Medical (Shenzhen) Co., Ltd.

결정일2024-08-15

제품 코드LOX

자문 위원회CV

결정Substantially Equivalent

기기 요약

Sapphire ULTRA Coronary Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is OrbusNeich Medical (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2024-08-15 under 510(k) number K233505. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Sapphire ULTRA Coronary Dilatation Catheter?

Sapphire ULTRA Coronary Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2024-08-15. The listed applicant is OrbusNeich Medical (Shenzhen) Co., Ltd.. The 510(k) number is K233505.

When did Sapphire ULTRA Coronary Dilatation Catheter receive FDA 510(k) clearance?

Sapphire ULTRA Coronary Dilatation Catheter received FDA 510(k) clearance on 2024-08-15, under 510(k) number K233505.

Who is the listed applicant for Sapphire ULTRA Coronary Dilatation Catheter?

The FDA 510(k) record lists OrbusNeich Medical (Shenzhen) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sapphire ULTRA Coronary Dilatation Catheter?

The FDA product code for Sapphire ULTRA Coronary Dilatation Catheter is LOX.

OrbusNeich Medical (Shenzhen) Co., Ltd.를 신청인으로 등재한 기타 기록

K261778JADE SCORE PTA Scoring Balloon Dilatation Catheter K253361Teleport Glide Microcatheter K242588COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)K233499Sapphire NC ULTRA Coronary Dilatation Catheter K241025JADE PLUS PTA Balloon Dilatation Catheter K231608Teleport XT Microcatheter

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