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
H965PKM131945S1 K121990 000
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H965PKM140344S1 K121990 000
H965PKM140343S1 K121990 000
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H965PKM137691S1 K121990 000
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H965PKM1220213S1 K121990 000
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H96560M18157121 K121990 000
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H96560M30709411 K121990 000
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H96560M2319721 K121990 000
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
H965PKM2322422S1 K121990 000
H965PKM61118182S1 K121990 000
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H965PKM210171S1 K121990 000
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H96560M1938861 K121990 000
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H965PKMR61010899S1 K121990 000
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