APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH

Endovascular Suturing System

APTUS ENDOSYSTEMS, INC.

The following data is part of a premarket notification filed by Aptus Endosystems, Inc. with the FDA for Aptus Heli-fx Guide - 22cm Deflectable Length; Aptus Heli-fx Guide - 28cm Deflectable Length; Aptus Heli-fx Applier With.

Pre-market Notification Details

Device IDK140036
510k NumberK140036
Device Name:APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH
ClassificationEndovascular Suturing System
Applicant APTUS ENDOSYSTEMS, INC. 271 GIBRALTAR DRIVE Sunnyvale,  CA  94089
ContactBurt Goodson
CorrespondentBurt Goodson
APTUS ENDOSYSTEMS, INC. 271 GIBRALTAR DRIVE Sunnyvale,  CA  94089
Product CodeOTD  
CFR Regulation Number870.3460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-01-07
Decision Date2014-02-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169647695 K140036 000
00643169647664 K140036 000
00643169647640 K140036 000
00643169647626 K140036 000
00643169647602 K140036 000
00643169647572 K140036 000
00643169647565 K140036 000

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