FDA.reportPublic FDA data

CLEARSTREAM TECHNOLOGIES LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96166663008906816CLEARSTREAM TECHNOLOGIES LTD.1N2026-01-01Moyne Upper Enniscorthy Wexford IE IRL

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1366071549833751P160024LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENTPRL2017-04-24
1366071916396666K222793WavelinQ™ GeneratorGEI2022-10-17
1366071589819207K212708Halo One Thin-Walled Guiding SheathDYB2021-09-23
1366072039529392K192313Halo One Thin-Walled Guiding SheathDYB2019-12-19
1366071735491724K192239WavelinQ Plus EndoAVF SystemPQK2019-10-17
1366071927278284K191532The Caterpillar and Caterpillar Micro Arterial Embolization DevicesKRD2020-02-04
1366071594950991K162656ESU-1 Electrosurgical GeneratorGEI2016-11-10
1366071568444060K130786SLEEK OTW PTA CATHETERLIT2013-05-03
1366071042359605K102035SLEEK OTW PTA CATHETERSLIT2010-12-01
1366071384561573K072947SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERSLIT2008-02-08
1366071309968849
1366071114778912
1366071178139770
1366071569668445
1366071585242135
1366071780749456
1366071994752367

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LIT32013-05-03
GEI22022-10-17
DYB22021-09-23
KRD12020-02-04
PQK12019-10-17
PRL12017-04-24