Celsius Thermocool products and Navistar Thermocool products

  • Model / Serial
    Lots 13027030 to 13044734
  • Product Classification
  • 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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
  • Manufacturer Parent Company (2017)
  • Source
    USFDA