FDA 510(k)

High Pressure Tubing

K-번호: K232388 · 2023-11-21

신청자Ningbo Dizegens Medical Science Co.,Ltd

결정일2023-11-21

제품 코드DXT

자문 위원회CV

결정Substantially Equivalent

기기 요약

High Pressure Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Dizegens Medical Science Co.,Ltd. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K232388. 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 High Pressure Tubing?

High Pressure Tubing is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Ningbo Dizegens Medical Science Co.,Ltd. The 510(k) number is K232388.

When did High Pressure Tubing receive FDA 510(k) clearance?

High Pressure Tubing received FDA 510(k) clearance on 2023-11-21, under 510(k) number K232388.

Who is the listed applicant for High Pressure Tubing?

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

What is the FDA product code for High Pressure Tubing?

The FDA product code for High Pressure Tubing is DXT.

Ningbo Dizegens Medical Science Co.,Ltd를 신청인으로 등재한 기타 기록

K232577Radial Compression Device

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.

공식 출처

FDA 데이터베이스에서 보기 →

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