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Devices
7FR Deflectable Tip Catheter and 5FR Deflectable Tip Catheter
Model / Serial
112 lots
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Japan, Europe, & Uruguay
Product Description
Deflectable Tip Catheter for cardiac mapping. || Mfg Part # Catalog # EU Part # || D-1078-35-S 107835S SW1078-035; || D-1078-63-S D5S06AL252RT 36A-07Q; || D-1078-78-S 107878S N/A; || D-1097-511-S 1097511S SW1097-511; || D-1097-554-S D708DL002RT 36F-32Q.
Manufacturer
Biosense Webster, Inc.
1 Event
Recall of 7FR Deflectable Tip Catheter and 5FR Deflectable Tip Catheter
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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
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