Product Code: LOX


Products Classified as LOX

865Catheters, Transluminal Coronary Angioplasty, PercutaneousPercutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.

Total Product Life Cycle (TPLC) Devices

865Catheters, Transluminal Coronary Angioplasty, PercutaneousPercutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.

FDA Consensus Standards

Catheters, Transluminal Coronary Angioplasty, Percutaneous [38909]21 CFR §870.5100 🔎

Pre-market Approvals for LOX

P870036VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEMMEDTRONICS INTERVENTIONAL VASCULAR
P790017D114S/NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION CATHETERMEDTRONIC IRELAND
P810046CROSS SAIL CORONARY DILATATION CATHETERADVANCED CARDIOVASCULAR SYSTEMS, INC.
P860019MAXXUM AND NC MAXXUM PTCA CATHETERSCIMED LIFE SYSTEMS, INC.
P950020FLEXTOME CUTTING BALLOON DILATATIONS DEVICEBoston Scientific Corp.

Pre-market Notifications for LOX

K220629Emerge Monorail PTCA Dilatation CatheterBoston Scientific
K220634NC TREK NEO Coronary Dilatation CatheterAbbott Vascular
K211807Sapphire NC 24OrbusNeich Medical (Shenzhen) Co., Ltd.
K211393Selethru(TM) NC PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.
K211349Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.
K210012Tamarin Blue PTCA RX Dilatation CatheterNatec Medical Ltd.
K203390Artimes Pro Balloon Dilatation CatheterBrosMed Medical Co., Ltd.
K202619KardiFlex PTCA Balloon Dilatation CatheterMedcaptain Life Science Co., Ltd.
K202578KardiFlex NC Coronary Dilatation CatheterMedcaptain Life Science Co., Ltd.
K200269Sapphire II PROOrbusNeich Medical Trading Inc.
K192344Sapphire NC Plus Coronary Dilatation CatheterOrbusNeich Medical Trading Inc.
K182699Selethru PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.
K181023Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation CatheterMeril Life Sciences Private Limited
K180921Sapphire II PRO Balloon Dilatation CatheterOrbusNeich Medical Trading Inc.
K180040NC TREKâ„¢ RX Coronary Dilatation Catheter; NC TREKâ„¢ OTW Coronary Dilatation Catheter; TREKâ„¢ RX Coronary Dilatation Catheter; TREKâ„¢ OTW Coronary Dilatation Catheter; MINI TREKâ„¢ RX Coronary Dilatation Catheter; MINI TREKâ„¢ OTW Coronary Dilatation CatheteAbbott Vascular

Global Unique Device Identification Database

00613994902924Catheters, transluminal coronary angioplasty, percutaneous
00613994902894Catheters, transluminal coronary angioplasty, percutaneous
00613994902863Catheters, transluminal coronary angioplasty, percutaneous
00613994902832Catheters, transluminal coronary angioplasty, percutaneous
00613994902801Catheters, transluminal coronary angioplasty, percutaneous
00613994902771Catheters, transluminal coronary angioplasty, percutaneous
00613994902740Catheters, transluminal coronary angioplasty, percutaneous
00613994902689Catheters, transluminal coronary angioplasty, percutaneous
00613994902658Catheters, transluminal coronary angioplasty, percutaneous
00613994902627Catheters, transluminal coronary angioplasty, percutaneous
00613994902597Catheters, transluminal coronary angioplasty, percutaneous
00613994902566Catheters, transluminal coronary angioplasty, percutaneous
00613994902535Catheters, transluminal coronary angioplasty, percutaneous
00613994902504Catheters, transluminal coronary angioplasty, percutaneous
00613994902498Catheters, transluminal coronary angioplasty, percutaneous

Maude Adverse Events

NC TRAVELER RXABBOTT VASCULAR2020-03-31
NC TREK RXABBOTT VASCULAR2020-03-31
NC EMERGEBOSTON SCIENTIFIC CORPORATION2020-03-31
NC TREK RXABBOTT VASCULAR2020-03-31
NC EMERGEBOSTON SCIENTIFIC CORPORATION2020-03-31
NC EMERGEBOSTON SCIENTIFIC CORPORATION2020-03-31
EMERGEBOSTON SCIENTIFIC CORPORATION2020-03-31
NC TREK RXABBOTT VASCULAR2020-03-31
NC TREK RXABBOTT VASCULAR2020-03-31
NC TREK RXABBOTT VASCULAR2020-03-31
NC EMERGEBOSTON SCIENTIFIC CORPORATION2020-03-31
EUPHORA RXMEDTRONIC MEXICO2020-03-31
EMERGE PUSHBOSTON SCIENTIFIC CORPORATION2020-03-30
NC EMERGEBOSTON SCIENTIFIC CORPORATION2020-03-30
NC TREK RXABBOTT VASCULAR2020-03-30
MAVERICKBOSTON SCIENTIFIC CORPORATION2020-03-30
TREK RX CORONARY DILATATION CATHETERABBOTT VASCULAR2020-03-30
TREK RX CORONARY DILATATION CATHETERABBOTT VASCULAR2020-03-30
NC EMERGEBOSTON SCIENTIFIC CORPORATION2020-03-29
NC QUANTUM APEXBOSTON SCIENTIFIC CORPORATION2020-03-29
NC EMERGEBOSTON SCIENTIFIC CORPORATION2020-03-27
QUANTUM MAVERICKBOSTON SCIENTIFIC CORPORATION2020-03-27
EMERGEBOSTON SCIENTIFIC CORPORATION2020-03-27
NC SPRINTER RXMEDTRONIC MEXICO2020-03-27
MAVERICKBOSTON SCIENTIFIC CORPORATION2020-03-26
NC EMERGEBOSTON SCIENTIFIC CORPORATION2020-03-26
PANTERA LEO 3.0/15BIOTRONIK AG, BUELACH, SWITZERLAND2020-03-26
EMERGEBOSTON SCIENTIFIC CORPORATION2020-03-26
PANTERA LEO 3.5/12BIOTRONIK AG, BUELACH, SWITZERLAND2020-03-26
EMERGEBOSTON SCIENTIFIC CORPORATION2020-03-26
NC EMERGEBOSTON SCIENTIFIC CORPORATION2020-03-26
NC QUANTUM APEXBOSTON SCIENTIFIC CORPORATION2020-03-26
TREK RX CORONARY DILATATION CATHETERABBOTT VASCULAR2020-03-26
NC TREK RXABBOTT VASCULAR2020-03-26
NC TREK RXABBOTT VASCULAR2020-03-26
SPRINTER LEGEND RXMEDTRONIC MEXICO2020-03-26
TREK RX CORONARY DILATATION CATHETERABBOTT VASCULAR2020-03-25
NC QUANTUM APEXBOSTON SCIENTIFIC CORPORATION2020-03-25
NC QUANTUM APEXBOSTON SCIENTIFIC CORPORATION2020-03-25
EMERGEBOSTON SCIENTIFIC CORPORATION2020-03-25
NC EMERGEBOSTON SCIENTIFIC CORPORATION2020-03-25
NC EMERGEBOSTON SCIENTIFIC CORPORATION2020-03-25
TREK RX CORONARY DILATATION CATHETERABBOTT VASCULAR2020-03-25
NC EUPHORA RXMEDTRONIC MEXICO2020-03-25
BOSTON SCIENTIFIC NC QUANTUM APEXBOSTON SCIENTIFIC CORP.2020-03-24
TREK RX CORONARY DILATATION CATHETERABBOTT VASCULAR2020-03-24
NC TREK RXABBOTT VASCULAR2020-03-24
NC TREK RXABBOTT VASCULAR2020-03-24
TREK RX CORONARY DILATATION CATHETERABBOTT VASCULAR2020-03-24
EMERGEBOSTON SCIENTIFIC CORPORATION2020-03-24
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