SPECTRANETICS VISISHEATH DILATOR SHEATH

Dilator, Vessel, For Percutaneous Catheterization

SPECTRANETICS CORP.

The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for Spectranetics Visisheath Dilator Sheath.

Pre-market Notification Details

Device IDK092378
510k NumberK092378
Device Name:SPECTRANETICS VISISHEATH DILATOR SHEATH
ClassificationDilator, Vessel, For Percutaneous Catheterization
Applicant SPECTRANETICS CORP. 96 TALAMINE CT. Colorado Springs,  CO  80907 -5159
ContactCheryl Hastings
CorrespondentCheryl Hastings
SPECTRANETICS CORP. 96 TALAMINE CT. Colorado Springs,  CO  80907 -5159
Product CodeDRE  
CFR Regulation Number870.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-08-05
Decision Date2009-11-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M204501216AA0 K092378 000
M204501214AA0 K092378 000
M204501212AA0 K092378 000
M204501116AA0 K092378 000
M204501114AA0 K092378 000
M204501112AA0 K092378 000
M204501016AA0 K092378 000
M204501014AA0 K092378 000
M204501012AA0 K092378 000

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