HYBRID Guidewire

Guide, Wire, Catheter, Neurovasculature

Balt USA, LLC

The following data is part of a premarket notification filed by Balt Usa, Llc with the FDA for Hybrid Guidewire.

Pre-market Notification Details

Device IDK182337
510k NumberK182337
Device Name:HYBRID Guidewire
ClassificationGuide, Wire, Catheter, Neurovasculature
Applicant Balt USA, LLC 29 Parker Irvine,  CA  92618
ContactNancy Xu
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeMOF  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2018-08-28
Decision Date2018-10-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00818053022852 K182337 000
00818053022746 K182337 000
00818053022753 K182337 000
00818053022760 K182337 000
00818053022777 K182337 000
00818053022784 K182337 000
00818053022791 K182337 000
00818053022807 K182337 000
00818053022814 K182337 000
00818053022739 K182337 000

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