FDA 510(k)

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K-번호: K242143 · 2024-12-23

신청자Shandong Int Medical Instruments Co., Ltd.

결정일2024-12-23

제품 코드DXT

자문 위원회CV

결정Substantially Equivalent

기기 요약

Angiography Injector is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Int Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2024-12-23 under 510(k) number K242143. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Angiography Injector?

Angiography Injector is a medical device that received FDA 510(k) clearance on 2024-12-23. The listed applicant is Shandong Int Medical Instruments Co., Ltd.. The 510(k) number is K242143.

When did Angiography Injector receive FDA 510(k) clearance?

Angiography Injector received FDA 510(k) clearance on 2024-12-23, under 510(k) number K242143.

Who is the listed applicant for Angiography Injector?

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

What is the FDA product code for Angiography Injector?

The FDA product code for Angiography Injector is DXT.

Shandong Int Medical Instruments Co., Ltd.를 신청인으로 등재한 기타 기록

K244038High Pressure Tubing

관련 기기 (코드: DXT)

K252652Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable SyrFortis Biosolutions Company Limited K252653ACIST Pro 진단 시스템 (019304); 처리 유닛 베드 마운트; AngioTouch 모듈; ACIST Pro 카트; 단일 트랜서듀어 케이블; 트리플 트랜서듀어 케이블Acist Medical Systems, Inc.K252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)Acist Medical Systems, Inc.K253048High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeShenzhen Maiwei Biotech Co., Ltd.K251788Extension tubeZhuhai DR Medical Instruments Co., Ltd.K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)Bayer Medical Care, Inc.

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