MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB

Catheter, Percutaneous

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronioc 7f Launcher Biopsy Guide Catheter, Model La7rvbb, Medtronic 8f Launcher Biopsy Catheter, Model La8rvbb.

Pre-market Notification Details

Device IDK030671
510k NumberK030671
Device Name:MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB
ClassificationCatheter, Percutaneous
Applicant MEDTRONIC VASCULAR 37A CHERRY HILL DR. Danvers,  MA  01923
ContactFred L Boucher
CorrespondentFred L Boucher
MEDTRONIC VASCULAR 37A CHERRY HILL DR. Danvers,  MA  01923
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-03
Decision Date2003-07-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994833235 K030671 000
00613994768933 K030671 000
10721902713498 K030671 000
10721902683104 K030671 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.