Target Detachable Coils

Device, Neurovascular Embolization

Stryker Neurovascular

The following data is part of a premarket notification filed by Stryker Neurovascular with the FDA for Target Detachable Coils.

Pre-market Notification Details

Device IDK161429
510k NumberK161429
Device Name:Target Detachable Coils
ClassificationDevice, Neurovascular Embolization
Applicant Stryker Neurovascular 47900 Bayside Parkway Fremont,  CA  94538 -2588
ContactKate Taylor
CorrespondentKate Taylor
Stryker Neurovascular 47900 Bayside Parkway Fremont,  CA  94538 -2588
Product CodeHCG  
CFR Regulation Number882.5950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-23
Decision Date2016-06-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327128413 K161429 000
07613327466386 K161429 000
07613327466393 K161429 000
07613327466409 K161429 000
07613327466416 K161429 000
07613327466423 K161429 000
07613327128307 K161429 000
07613327128345 K161429 000
07613327128352 K161429 000
07613327128369 K161429 000
07613327128376 K161429 000
07613327128383 K161429 000
07613327128406 K161429 000
07613327466379 K161429 000

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