About the database
How to use the database
Download the data
FAQ
Credits
Devices
Celsius Thermocool products and Navistar Thermocool products
Model / Serial
Lots 13027030 to 13044734
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
FL, iL, MA, MI, OH, OK and Belguin, Netherlands, Australia, Japan, Korea, India, Sri Lanka, New Zealand, China, Hong Kong, Singapore, Pakistan, Canada
Product Description
Thermocool Irrigated Catheters || Celsius || LABEL US Part Number# EU CATALOG # || L-1189-01-S D17TCBLRT 35Q-13R PMA; || L-1189-02-S D17TCDLRT 35Q-33R PMA; || L-1189-03-S D17TCFLRT 35Q-53R PMA; || L-1189-04-S D17TCJLRT 35Q-73R PMA; || L-1189-15-S D71TCB5L252RT 35Q-17Q EXPORT; || L-1189-16-S D71TCD5L252RT 35Q-37Q EXPORT; || L-1189-17-S D71TCF5L252FT 35Q-57Q EXPORT; || L-1189-03-S D71TFL252RT 35R-53R EXPORT; || L-1192-03-S D71TFL252RT 35R-53R EXPORT; || L-1192-15-S D71TB5L252RT 35R-17R EXPORT; || L-1192-16-S D7ITD5L252RT 35R-37R EXPORT; || L-1189-02-SI D17TCDLRTI N/A IDE; || L-1189-15-SI D71TCB5L252RTI N/A IDE; || L-1189-16-SI D71TCD5L252RTI N/A IDE; || L-1189-17-SI D71CF5L252RTI N/A IDE || Navistar || LABEL US Part Number# EU CATALOG # || L-1192-17-S D71TF5L252RT 35R-57R EXPORT; || L-1197-14-S NI75TCBH 34H-17M PMA; || L-1197-15-S NI75TCCH 34H-27M PMA; || L-1197-16-S NI75TCDH 34H-37M PMA; || L-1197-17-S NI75TCFH 34H-57M PMA; || L-1197-18-S NI75TCJH 34H-J7M PMA; || L-1208-05-S NS75TBCT252HS 34G-17M PMA; || L-1208-06-S NS75TCCT252HS 34G-27M PMA; || L-1208-07-S NS75TDCT252HS 34G-37M PMA; || L-1208-08-S NS75TFCT252HS 34G-57M PMA; || L-1197-14-SI NI75TCBHI N/A IDE; || L-1197-15-SI NI75TCCHI N/A IDE; || L-1197-16-SI NI75TCDHI N/A IDE; || L-1197-17-SI NI75TCFHI N/A IDE; || L-1197-18-SI NI75TCJHI N/A IDE; || L-1208-05-SI NS75TBCT252HSI N/A IDE; || L-1208-06-SI NS75TCCT252HSI N/A IDE; || L-1208-07-SI NS75TDCT252HSI N/A IDE; || L-1208-08-SI NS75TFCT252HSI N/A IDE
Manufacturer
Biosense Webster, Inc.
1 Event
Recall of Celsius Thermocool products and Navistar Thermocool products
{{ $t('card.reduce') }}
{{ $tc('card.more', left) }}
Manufacturer
Biosense Webster, Inc.
Manufacturer Address
Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
Manufacturer Parent Company (2017)
Johnson & Johnson
Source
USFDA
Language
English
Français
Español
한국어