FDA 510(k)

Cronus HP - High Pressure Peripheral Balloon Catheter

K-번호: K151141 · 2016-01-14

결정일2016-01-14

제품 코드LIT

자문 위원회CV

결정Substantially Equivalent

기기 요약

Cronus HP - High Pressure Peripheral Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Medical Corporation. It received FDA 510(k) clearance on 2016-01-14 under 510(k) number K151141. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Cronus HP - High Pressure Peripheral Balloon Catheter?

Cronus HP - High Pressure Peripheral Balloon Catheter is a medical device that received FDA 510(k) clearance on 2016-01-14. The listed applicant is Nipro Medical Corporation. The 510(k) number is K151141.

When did Cronus HP - High Pressure Peripheral Balloon Catheter receive FDA 510(k) clearance?

Cronus HP - High Pressure Peripheral Balloon Catheter received FDA 510(k) clearance on 2016-01-14, under 510(k) number K151141.

Who is the listed applicant for Cronus HP - High Pressure Peripheral Balloon Catheter?

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

What is the FDA product code for Cronus HP - High Pressure Peripheral Balloon Catheter?

The FDA product code for Cronus HP - High Pressure Peripheral Balloon Catheter is LIT.

Nipro Medical Corporation를 신청인으로 등재한 기타 기록

K261399ELISIO™-HX K253047PRESSONE™K260533ELISIO™-H K222852Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle K212677aboNT SYRINGE K190037Cronus HP PTA Balloon Catheter

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