SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER

Introducer, Catheter

ST. JUDE MEDICAL

The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Swartz Braided Transseptal Guiding Introducer.

Pre-market Notification Details

Device IDK052644
510k NumberK052644
Device Name:SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER
ClassificationIntroducer, Catheter
Applicant ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka,  MN  55345 -2126
ContactGlenn Jacques
CorrespondentGlenn Jacques
ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka,  MN  55345 -2126
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-26
Decision Date2005-12-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05414734205832 K052644 000
05414734205641 K052644 000
05414734205634 K052644 000
05414734205627 K052644 000
05414734205610 K052644 000
05414734205597 K052644 000
05414734205580 K052644 000
05414734205573 K052644 000
05414734205559 K052644 000
05414734205542 K052644 000
05414734205535 K052644 000
05414734205658 K052644 000
05414734205672 K052644 000
05414734205818 K052644 000
05414734205801 K052644 000
05414734205795 K052644 000
05414734205788 K052644 000
05414734205771 K052644 000
05414734205764 K052644 000
05414734205757 K052644 000
05414734205740 K052644 000
05414734205733 K052644 000
05414734205702 K052644 000
05414734205511 K052644 000

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