LOX
Sapphire II PRO
- Advisory panel
- Cardiovascular
- Total cleared
- 86
Adverse events under product code LOX
product code LOX- Death
- 190
- Injury
- 1,498
- Malfunction
- 9,670
- Total
- 11,358
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code LOX
- K252116 — Firefighter Pro PTCA Balloon Catheter
- K254022 — FLASH Flex Aorto-Ostial Angioplasty System
- K252295 — Ryurei
- K251970 — Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
- K242969 — Pantera Pro; Pantera LEO
- K233499 — Sapphire NC ULTRA Coronary Dilatation Catheter
- K233505 — Sapphire ULTRA Coronary Dilatation Catheter
- K233729 — Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58
- K223189 — Firefighter NC Pro PTCA Balloon Catheter
- K230374 — Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)
- K230705 — POT PTCA Balloon Dilatation Catheter
- K223022 — SC HONKYTONK PTCA Balloon Dilatation Catheter
- K222538 — NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter
- K220634 — NC TREK NEO Coronary Dilatation Catheter
- K220629 — Emerge Monorail PTCA Dilatation Catheter
- K212393 — OPN NC PTCA Dilatation Catheter
- K211349 — Selebrek PTCA Balloon Dilatation Catheter
- K211807 — Sapphire NC 24
- K210012 — Tamarin Blue PTCA RX Dilatation Catheter
- K211393 — Selethru(TM) NC PTCA Balloon Dilatation Catheter
- K202578 — KardiFlex NC Coronary Dilatation Catheter
- K202619 — KardiFlex PTCA Balloon Dilatation Catheter
- K203390 — Artimes pro Balloon Dilatation Catheter
- K200269 — Sapphire II PRO
- K192344 — Sapphire NC Plus Coronary Dilatation Catheter
- K182699 — Selethru PTCA Balloon Dilatation Catheter
- K180040 — NC TREK RX Coronary Dilatation Catheter; NC TREK OTW Coronary Dilatation Catheter; TREK RX Coronary Dilatation Catheter; TREK OTW Coronary Dilatation Catheter; MINI TREK RX Coronary Dilatation Catheter; MINI TREK OTW Coronary Dilatation Catheter; MINI TREK II OTW Coronary Dilatation Catheter
- K180921 — Sapphire II PRO Balloon Dilatation Catheter
- K181023 — Mozec Rx PTCA Balloon Dilatation Catheter, Mozec NC Rx PTCA Balloon Dilatation Catheter
- K172264 — OTW Takeru PTCA Balloon Dilatation Catheter
- K173680 — Sapphire II PRO
- K173581 — Gallant PTCA Dilatation Catheter
- K170941 — RX NC Takeru PTCA Balloon Dilatation Catheter
- K162625 — SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters
- K163372 — RX Takeru Balloon Dilatation Catheter
- K163660 — Pantera LEO
- K162434 — NC Gallant PTCA Catheter
- K163114 — Sapphire II PRO
- K163174 — Emerge PTCA Dilatation Catheter
- K163200 — Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete
- K160985 — Pantera Pro
- K162209 — Sapphire NC Plus
- K153742 — Apollo Balloon Dilatation Catheter
- K160961 — Mozec NC-Rx PTCA Baloon Dilatation Catheter
- K153682 — Chocolate XD PTCA Balloon Catheter
- K160823 — NC Quantum Apex PTCA Dilatation Catheter
- K152485 — FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm
- K141933 — FILAO NC RX PTCA DILATATION CATHETER
- K150292 — Chocolate PTCA Balloon Catheter
- K143480 — Euphora Rapid Exchange Balloon Dilatation Catheter
- K143160 — FOXTROT NC PTCA Balloon Catheter
- K133852 — APOLLO BALLOON DILATATION CATHETER
- K141025 — ARTIMES BALLOON DILATATION CATHETER
- K141090 — NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER
- K141236 — NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
- K134031 — THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER
- K133633 — CHOCOLATE PTCA BOLLOON CATHETER
- K131169 — MOZEC - RX PTCA BALLOON DILATATION CATHETER
- K123473 — HOPER PTCA BALLOON CATHETER
- K131450 — FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0
- K130391 — EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT
- K123279 — MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN
- K123264 — DK-PTCA BALLOON CATHETER
- K112735 — TAMARIN BLUE PTCA RX DILATATION CATHETER
- K122178 — FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1
- K121196 — EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
- K121667 — NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)
- K113775 — FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM
- K121681 — GLIDER PTCA BALLOON CATHETER
- K121222 — TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER
- K113220 — EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
- K113464 — NC TREK OTW CORONARY DILATATION CATHETER
- K111544 — GLIDER PTCA BALLOON CATHETER
- K103808 — SAPPHIRE NC
- K111284 — FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM
- K103657 — SAPPHIRE
- K110133 — EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER
- K110617 — MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER
- K110134 — NC TREK RX CORONARY DILATATION CATHETER
- K103110 — MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER
- K103153 — VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER
- K103095 — SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON
- K896108 — THE PILOT SCIMED TORQUE DEVICE
- K861847 — ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE
- K843944 — PTCA BALLOON CATHETERS & ACCESSORIES
- K820410 — HEMOTEC HEPCON/SYSTEM FOUR & FOUR P
Data sourced from openFDA. This site is unofficial and independent of the FDA.