FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10

Catheter, Steerable

MEDTRONIC CRYOCATH LP

The following data is part of a premarket notification filed by Medtronic Cryocath Lp with the FDA for Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model 3fc12, 3fc10.

Pre-market Notification Details

Device IDK102176
510k NumberK102176
Device Name:FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10
ClassificationCatheter, Steerable
Applicant MEDTRONIC CRYOCATH LP 16771 CHEMIN STE-MARIE Kirkland,  CA H9h5h3
ContactKari Lahti
CorrespondentKari Lahti
MEDTRONIC CRYOCATH LP 16771 CHEMIN STE-MARIE Kirkland,  CA H9h5h3
Product CodeDRA  
CFR Regulation Number870.1280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-03
Decision Date2010-09-01
Summary:summary

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