TPLC - Total Product Life Cycle

• Device: tube, tracheal (w/wo connector)
• Product Code: BTR
• Regulation Number: 868.5730
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
A.R GUIDE IN MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
BRYAN MEDICAL , INC.
	SUBSTANTIALLY EQUIVALENT	1
BRYAN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	1
ETVIEW LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI YIKANG MEDICAL INSTRUMENT GROUP CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
NEVAP, INC.
	SUBSTANTIALLY EQUIVALENT	1
SALTER LABS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SECURISYN MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEXMEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
TIANJIN MEDIS MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VENNER MEDICAL (SINGAPORE) PTE LTD
	SUBSTANTIALLY EQUIVALENT	1
WELL LEAD MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ZHANJIANG STAR ENTERPRISE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	975	975
2019	1379	1379
2020	1070	1070
2021	1329	1329
2022	1132	1132
2023	1134	1134

Recalls
Manufacturer		Recall Class	Date Posted
1	Centurion Medical Products Corporation	I	Jul-30-2019
2	Covidien	II	Apr-01-2023
3	Flexicare Medical Ltd.	I	Nov-26-2020
4	Smiths Medical ASD Inc.	II	Oct-27-2021
5	TELEFLEX LLC	I	Jun-29-2023
6	TELEFLEX LLC	II	Jan-23-2023
7	TELEFLEX MEDICAL INC	II	Jul-10-2020
8	Teleflex Medical	I	Sep-09-2019
9	Teleflex Medical	I	Jun-19-2019
10	Teleflex Medical	II	May-29-2019
11	Teleflex Medical Europe Ltd	II	Aug-19-2021