VASCULAR PROBE, VASCULAR PROBE ES

Dilator, Vessel, Surgical

SYNOVIS LIFE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Synovis Life Technologies, Inc. with the FDA for Vascular Probe, Vascular Probe Es.

Pre-market Notification Details

Device IDK130896
510k NumberK130896
Device Name:VASCULAR PROBE, VASCULAR PROBE ES
ClassificationDilator, Vessel, Surgical
Applicant SYNOVIS LIFE TECHNOLOGIES, INC. 2575 UNIVERSITY AVE. W. St. Paul,  MN  55114
ContactStephani K Ayala
CorrespondentStephani K Ayala
SYNOVIS LIFE TECHNOLOGIES, INC. 2575 UNIVERSITY AVE. W. St. Paul,  MN  55114
Product CodeDWP  
CFR Regulation Number870.4475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-01
Decision Date2013-04-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50085412532696 K130896 000
50085412532535 K130896 000
50085412532542 K130896 000
50085412532559 K130896 000
50085412532566 K130896 000
50085412532573 K130896 000
50085412532580 K130896 000
50085412532597 K130896 000
50085412532603 K130896 000
50085412532610 K130896 000
50085412532627 K130896 000
50085412532634 K130896 000
50085412532641 K130896 000
50085412532658 K130896 000
50085412532665 K130896 000
50085412532672 K130896 000
50085412532689 K130896 000
50085412532528 K130896 000

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