FDA 510(k)

Bard Power-Injectable Implantable Ports (PowerPorts®)

K-번호: K181446 · 2019-07-08

결정일2019-07-08

제품 코드LJT

자문 위원회HO

결정Substantially Equivalent

기기 요약

Bard Power-Injectable Implantable Ports (PowerPorts®) is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2019-07-08 under 510(k) number K181446. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Bard Power-Injectable Implantable Ports (PowerPorts®)?

Bard Power-Injectable Implantable Ports (PowerPorts®) is a medical device that received FDA 510(k) clearance on 2019-07-08. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K181446.

When did Bard Power-Injectable Implantable Ports (PowerPorts®) receive FDA 510(k) clearance?

Bard Power-Injectable Implantable Ports (PowerPorts®) received FDA 510(k) clearance on 2019-07-08, under 510(k) number K181446.

Who is the listed applicant for Bard Power-Injectable Implantable Ports (PowerPorts®)?

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

What is the FDA product code for Bard Power-Injectable Implantable Ports (PowerPorts®)?

The FDA product code for Bard Power-Injectable Implantable Ports (PowerPorts®) is LJT.

C.R. Bard, Inc.를 신청인으로 등재한 기타 기록

K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit K252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)K251864Rubber Utility Catheter K251186Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)K241334Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,

67개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

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