FDA.reportPublic FDA data

ACCESS SCIENTIFIC, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30095492293009549229ACCESS SCIENTIFIC, LLC1N2020-04-253910 Sorrento Valley Blvd Ste 200 San Diego CA US 92121

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
00859821006759POWERWAND - Dressing Change Kit w/Statlock1-858-259-8333cs@accessscientific.com
10859821006114CVC WAND - The CVC WAND Safety Introducer with Valved Peelabel Sheath and Integral Needle Protection1-858-259-8333cs@accessscientific.com
10859821006121CVC WAND XL - The CVC WAND Safety Introducer with Valved Peelabel Sheath1-858-259-8333cs@accessscientific.com
10859821006138PICC WAND - The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection1-858-259-8333cs@accessscientific.com
10859821006145PICC WAND - The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection1-858-259-8333cs@accessscientific.com
10859821006374POWERWAND - POWERWAND Dressing Change Kit with StatLock1-858-259-8333cs@accessscientific.com
10859821006381POWERWAND - POWERWAND Dressing Change Kit with Zpad1-858-259-8333cs@accessscientific.com
10859821006459POWERWAND - Deluxe Dressing Change Kit W/Zpad1-858-259-8333cs@accessscientific.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1509291137741655K973958GENERAL PURPOSE ATL NEEDLE GUIDE KITITX1998-01-22
1509291616089227K183066The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr ModelDYB2019-07-25
1509291028265025K182243The CVC WAND Safety Introducer with Valved Peelable SheathDYB2018-09-18
1509291942654106K181563The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD TechnologyDQY2018-09-26
1509291563592855K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelDYB2016-11-17
1509291389109690K131300THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETERDYB2013-06-07
1509291118520700K131148THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATHDYB2013-09-04
1509291222995262
1509291453792517
1509291563305302

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DYB52019-07-25
DQY12018-09-26
ITX11998-01-22

PMN#

GUDID#

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