Kaneka Medical America LLC

Matched from indexed company URL: KANEKA CORP.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2435151	2435151	Kaneka Medical America LLC	1	Y	2026-01-01	623 Fifth Avenue New York NY US 10022
3009761573	3009761573	KANEKA MEDIX CORPORATION KANAGAWA PLANT	1	N	2026-01-01	225-1 Aza Deguchi, Yamakita Yamakita-machi Ashigara-Kami-gun Kanagawa JP 2580113
3014758755	3014758755	KANEKA AMERICAS HOLDING INC	1	N	2026-01-01	7979 Gateway Blvd Newark CA US 94560
3031550970	3031550970	KANEKA MEDICAL VIETNAM Co.,Ltd.	1	N	2026-01-01	35 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 GUDID	Product	Phone	Email
00810201980007	SurfRider 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.	7079532615	darci@tplconsulting.net
00810201980014	SurfRider 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.	7079532615	darci@tplconsulting.net
04540778193710	i-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) 526-3522	xx@xx.xx
04540778193727	i-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) 526-3522	xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
347538	1430585149	K251668	SurfRider 13 Microcatheter	QJP	2026-01-05
144612	1888905219	K210638	i-ED COIL System	HCG	2021-03-26
328518	1888905219	K210638	i-ED COIL System	HCG	2021-03-26
328518	1669513610	K172264	OTW Takeru PTCA Balloon Dilatation Catheter	LOX	2018-03-19
328518	1642200737	K170941	RX NC Takeru PTCA Balloon Dilatation Catheter	LOX	2017-07-07
144612	1996704147	K170247	Lacriflow CL	OKS	2017-04-18
328518	1653217226	K163372	RX Takeru Balloon Dilatation Catheter	LOX	2017-04-07
144612	1710466092	K121301	XPRESSWAY RX CATHETER (6F LD-VERISON)	QEZ	2012-07-30
144612	1890717006	K120886	LACRIFAST	OKS	2012-12-17
144612	1118856797	K101839	KANEKA PHARMA AMERICA XPRESS-WAY RX	QEZ	2010-10-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LOX	3	2018-03-19
HCG	2	2021-03-26
OKS	2	2017-04-18
QEZ	2	2012-07-30
QJP	1	2026-01-05

PMA#

LIPOSORBER LA-15 System

2022-06-30

KANEKA PHARMA AMERICA CORP.546 Fifth Ave., 21st Floornew York, NY 10036 PMA NumberP910018 Supplement NumberS034 Date Received05/31/2022 Decision Date06/30/2022 Product Code MMY Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supple...

LIPOSORBER LA-15 System

2022-04-29

KANEKA PHARMA AMERICA CORP.546 Fifth Ave., 21st Floornew York, NY 10036 PMA NumberP910018 Supplement NumberS033 Date Received03/30/2022 Decision Date04/29/2022 Product Code MMY Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supple...