PICC CONVENIENCE KIT

Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

NAVILYST MEDICAL, INC.

The following data is part of a premarket notification filed by Navilyst Medical, Inc. with the FDA for Picc Convenience Kit.

Pre-market Notification Details

Device IDK121990
510k NumberK121990
Device Name:PICC CONVENIENCE KIT
ClassificationCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Applicant NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough,  MA  01752
ContactMarion W Gordon
CorrespondentMarion W Gordon
NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough,  MA  01752
Product CodeLJS  
CFR Regulation Number880.5970 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-06
Decision Date2012-08-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H965PKM140345S1 K121990 000
H965PKM131944S1 K121990 000
H965PKM131935S1 K121990 000
H965PKM131933S1 K121990 000
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H965PKM130862S1 K121990 000
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H965PKM140344S1 K121990 000
H965PKM140343S1 K121990 000
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H965PKM1220213S1 K121990 000
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H96560M30709411 K121990 000
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H96560M2208521 K121990 000
H96560M18157111 K121990 000
H965PKM010536S1 K121990 000
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H965PKM1220226S1 K121990 000
H965PKM1205315S1 K121990 000
H965PKM1220227S1 K121990 000
H96560M611052531 K121990 000
H96560M611052521 K121990 000
H96560M610661441 K121990 000
H965PKM160312S1 K121990 000
H965PKM223592S1 K121990 000
H96560M1633931 K121990 000
H965PKM1410019S1 K121990 000
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H965PKM61118182S1 K121990 000
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H96560M1938861 K121990 000
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H965PKMR61010899S1 K121990 000
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