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Kaneka Medical America LLC

Matched from indexed company URL: KANEKA CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
24351512435151Kaneka Medical America LLC1Y2026-01-01623 Fifth Avenue New York NY US 10022
30097615733009761573KANEKA MEDIX CORPORATION KANAGAWA PLANT1N2026-01-01225-1 Aza Deguchi, Yamakita Yamakita-machi Ashigara-Kami-gun Kanagawa JP 2580113
30147587553014758755KANEKA AMERICAS HOLDING INC1N2026-01-017979 Gateway Blvd Newark CA US 94560
30315509703031550970KANEKA MEDICAL VIETNAM Co.,Ltd.1N2026-01-0135 VSIP Street 6, Vietnam - Singapore Industrial Park, An Phu Wo Ho Chi Minh VN NA

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00810201980007SurfRider 13 Microcatheter - SurfRider 13 Microcatheters are single lumen devices designed to aid the physician in accessing distal neuro vasculature when used with a guide catheter and steerable guidewire. There are two models of the SurfRider 13 Microcatheter, steam shapeable straight tip and a pre-shaped J tip. Both have an effective length of 165cm. The microcatheter is packaged and sterilized with the shaping mandrel and an intruder sheath. This model is the straight tip.7079532615darci@tplconsulting.net
00810201980014SurfRider 13 Microcatheter - SurfRider 13 Microcatheters are single lumen devices designed to aid the physician in accessing distal neuro vasculature when used with a guide catheter and steerable guidewire. There are two models of the SurfRider 13 Microcatheter, steam shapeable straight tip and a pre-shaped J tip. Both have an effective length of 165cm. The microcatheter is packaged and sterilized with the shaping mandrel and an intruder sheath. This model is the pre-shaped tip.7079532615darci@tplconsulting.net
04540778193710i-ED COIL - The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.(800) 526-3522xx@xx.xx
04540778193727i-ED COIL - The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.(800) 526-3522xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3475381430585149K251668SurfRider 13 MicrocatheterQJP2026-01-05
1446121888905219K210638i-ED COIL SystemHCG2021-03-26
3285181888905219K210638i-ED COIL SystemHCG2021-03-26
3285181669513610K172264OTW Takeru PTCA Balloon Dilatation CatheterLOX2018-03-19
3285181642200737K170941RX NC Takeru PTCA Balloon Dilatation CatheterLOX2017-07-07
1446121996704147K170247Lacriflow CLOKS2017-04-18
3285181653217226K163372RX Takeru Balloon Dilatation CatheterLOX2017-04-07
1446121710466092K121301XPRESSWAY RX CATHETER (6F LD-VERISON)QEZ2012-07-30
1446121890717006K120886LACRIFASTOKS2012-12-17
1446121118856797K101839KANEKA PHARMA AMERICA XPRESS-WAY RXQEZ2010-10-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LOX32018-03-19
HCG22021-03-26
OKS22017-04-18
QEZ22012-07-30
QJP12026-01-05

PMA#

PMN#

GUDID#

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