FDA 510(k)

Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool

K-번호: K192996 · 2019-11-21

결정일2019-11-21

제품 코드DQY

자문 위원회CV

결정Substantially Equivalent

기기 요약

Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2019-11-21 under 510(k) number K192996. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool?

Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool is a medical device that received FDA 510(k) clearance on 2019-11-21. The listed applicant is Biotronik, Inc.. The 510(k) number is K192996.

When did Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool receive FDA 510(k) clearance?

Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool received FDA 510(k) clearance on 2019-11-21, under 510(k) number K192996.

Who is the listed applicant for Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool?

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

What is the FDA product code for Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool?

The FDA product code for Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool is DQY.

Biotronik, Inc.를 신청인으로 등재한 기타 기록

K261074BIOMONITOR IV (471155)K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter K242969Pantera Pro; Pantera LEO K240787Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)K241711Oscar Peripheral Multifunctional Catheter system K230375BIOMONITOR IV

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