FDA 510(k)

OPTRELL™ Mapping Catheter with TRUEref™ Technology

K-번호: K230253 · 2023-03-02

결정일2023-03-02

제품 코드MTD

자문 위원회CV

결정Substantially Equivalent

기기 요약

OPTRELL™ Mapping Catheter with TRUEref™ Technology is the device name listed in this FDA 510(k) record. The listed applicant is Biosense Webster, Inc.. It received FDA 510(k) clearance on 2023-03-02 under 510(k) number K230253. The device is classified under product code MTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the OPTRELL™ Mapping Catheter with TRUEref™ Technology?

OPTRELL™ Mapping Catheter with TRUEref™ Technology is a medical device that received FDA 510(k) clearance on 2023-03-02. The listed applicant is Biosense Webster, Inc.. The 510(k) number is K230253.

When did OPTRELL™ Mapping Catheter with TRUEref™ Technology receive FDA 510(k) clearance?

OPTRELL™ Mapping Catheter with TRUEref™ Technology received FDA 510(k) clearance on 2023-03-02, under 510(k) number K230253.

Who is the listed applicant for OPTRELL™ Mapping Catheter with TRUEref™ Technology?

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

What is the FDA product code for OPTRELL™ Mapping Catheter with TRUEref™ Technology?

The FDA product code for OPTRELL™ Mapping Catheter with TRUEref™ Technology is MTD.

Biosense Webster, Inc.를 신청인으로 등재한 기타 기록

K252972CARTO™ 3 EP Navigation System V8.4 K254085CARTO™ 3 EP Navigation System V9.0 with PIU Plus K252302CARTO™ 3 EP Navigation System V8.1 K241540NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter K240050SOUNDSTAR™ CRYSTAL Ultrasound Catheter K231207CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)

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