FDA.reportPublic FDA data

Breskella Halteh

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30088818093008881809Breskella Halteh1N2026-01-0147900 Bayside Pkwy -- Fremont CA US 94538

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1255231799103106P180031Neuroform Atlas® Stent SystemQCA2019-05-16
1255231109464444P170024Surpass Streamline Flow DiverterOUT2018-07-13
1255231945695012K994155EXCELSIOR 1018 MICROCATHETERKRA2000-08-03
1255231446669212K993418FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COILHCG2000-01-21
1255231024131330K926243ANGIOGRAPHIC CATHETERDQO1993-08-16
1255231004876062K242289Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped MicrocatheterQJP2025-03-21
1255231487777953K242243Target Detachable CoilsHCG2024-08-29
1255231808149479K222533Target Tetra Detachable CoilsHCG2022-12-14
1255231063925495K183464AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)NRY2019-03-13
1255231250772311K183463AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cmDQY2019-03-13
1255231047440689K173841AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cmNRY2018-03-18
1255231389383527K163259AXS Offset Delivery Assist CatheterDQY2017-07-28
1255231857476565K161429Target Detachable CoilsHCG2016-06-22
1255231762949219K153658Target Detachable CoilsHCG2016-05-19
1255231041983666K152876LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CMDQY2016-01-08
1255232014806834K151667AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cmDQY2015-11-13
1255231729031426K142565Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped MicrocatheterDQY2014-11-14
1255231305747323K123377TARGET DETACHABLE COILHCG2012-11-30
1255231340159645K122576TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANTMJN2013-01-11
1255231663328532K113778EXCELSIOR XT-27 MICROCATHETERDQY2012-04-20
1255232034033796K050700MATRIX STRETCH RESISTANT (SR) COILSHCG2005-04-15
1255231529000652K042568EXCELSIOR 1018 AND SL-10 MICROCATHETERSDQY2004-10-15
1255231223832643K042539GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COILHCG2004-10-19
1255231099988460K031049GUGLIELMI DETACHABLE COIL (GDC)HCG2003-08-01
1255231472566669K030475GDC STRETCH RESISTANT DETACHABLE COILHCG2003-03-14
1255231119859070K013789EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189DQY2001-12-06
1255231012070115K002181GDC ULTRASOFT COILHCG2000-08-11
1255231342649522H050001
1255231047933528H020002
1255231547922447

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HCG112024-08-29
DQY82019-03-13
NRY22019-03-13
QJP12025-03-21
QCA12019-05-16
OUT12018-07-13
MJN12013-01-11
KRA12000-08-03
DQO11993-08-16