LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)

Bronchoscope (flexible Or Rigid)

BRONCUS MEDICAL INC

The following data is part of a premarket notification filed by Broncus Medical Inc with the FDA for Lungpoint Tools (lungpoint Sheath, Lungpoint Dilation Balloon).

Pre-market Notification Details

Device IDK131234
510k NumberK131234
Device Name:LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)
ClassificationBronchoscope (flexible Or Rigid)
Applicant BRONCUS MEDICAL INC 1400 N. Shoreline Blvd., Bldg A, Suite 8 Mountain View,  CA  94043
ContactMahtab Fatemi
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2013-05-01
Decision Date2013-10-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00856571007234 K131234 000
00856571007074 K131234 000
00856571007067 K131234 000
00856571007029 K131234 000
00856571007296 K131234 000

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.