Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- DRKDc-Defibrillator, High Energy, (Including Paddles)3Product Code
- DRLTester, Defibrillator2Product Code
- DRMCompressor, Cardiac, External2Product Code
- DRNDevice, Counter-Pulsating, External2Product Code
- DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)2Product Code
- DRPTourniquet, Automatic Rotating2Product Code
- DWJSystem, Thermal Regulating2Product Code
- DXECatheter, Embolectomy2Product Code
- DXFCatheter, Septostomy2Product Code
- JOWSleeve, Limb, Compressible2Product Code
- LDDDc-Defibrillator, Low-Energy, (Including Paddles)2Product Code
- LHXTrousers, Anti-Shock2Product Code
- LIXAid, Cardiopulmonary Resuscitation2Product Code
- LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous2Product Code
- MKJAutomated External Defibrillators (Non-Wearable)3Product Code
- MMXDevice, Percutaneous Retrieval2Product Code
- MPCAtrial Defibrillator3Product Code
- MPDAuxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator2Product Code
- MPEAuxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker2Product Code
- NSAOver-The-Counter Automated External Defibrillator3Product Code
- NZEHyperthermia Monitor2Product Code
- PJBCatheter Remote Control System2Product Code
- PLAEsophageal Thermal Regulation And Gastric Suctioning Device2Product Code
- PMJCpr Aid Feedback Device (No Software)2Product Code
- PMKCpr Aid Device Without Feedback1Product Code
- PPSSleeve, Head And Neck, Compressible2Product Code
- QEWPeripheral Mechanical Thrombectomy With Aspiration2Product Code
- QEXCoronary Mechanical Thrombectomy With Aspiration2Product Code
- QEYMechanical Thrombolysis Catheter2Product Code
- QEZAspiration Thrombectomy Catheter2Product Code
- K253925Aventus Thrombectomy System2Cleared 510(K)
- K252509AlphaVac Multipurpose Mechanical Aspiration System F18852Cleared 510(K)
- K251312Vesalio Peripheral System2Cleared 510(K)
- K251488FLOWRUNNER Aspiration System2Cleared 510(K)
- K243549JETi Hydrodynamic Thrombectomy System2Cleared 510(K)
- K250013VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP)2Cleared 510(K)
- K240397AlphaVac MMA F1885 System (H787253020)2Cleared 510(K)
- K232458JETi™Hydrodynamic Thrombectomy System2Cleared 510(K)
- K213388AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System2Cleared 510(K)
- K213565JETi AIO Peripheral Thrombectomy System2Cleared 510(K)
- K212199ASAP Aspiration Catheter, ASAPLP Aspiration Catheter2Cleared 510(K)
- K213166Thrombuster II Aspiration Catheter2Cleared 510(K)
- K211081AlphaVac Multipurpose Mechanical Aspiration (MMA) System2Cleared 510(K)
- K201998JETi AIO Peripheral Thrombectomy System2Cleared 510(K)
- K200871Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator2Cleared 510(K)
- K193197QuickClear Mechanical Thrombectomy System2Cleared 510(K)
- K192439JETi Peripheral Thrombectomy System2Cleared 510(K)
- K190619Aspiron(TM) Aspiration Catheter2Cleared 510(K)
- K183403JETi 88 Peripheral Thrombectomy System2Cleared 510(K)
- K182232Octane Mechanical Thrombectomy System2Cleared 510(K)
- K173266Octane aspiration system2Cleared 510(K)
- K172000ClearLumen II Peripheral Thrombectomy System2Cleared 510(K)
- K163051ClearLumen II Peripheral Thrombectomy System2Cleared 510(K)
- K161786ClearLumen II Thrombectomy System2Cleared 510(K)
- K140296CLEARLUMEN THROMBECTOMY SYSTEM2Cleared 510(K)
- K131998ASPIRE RX-LP6 ASPIRATION CATHETER2Cleared 510(K)
- K132155Merit ASAPLP Aspiration Catheter2Cleared 510(K)
- K130536EXPORT ADVANCE ASPIRATION CATHETER2Cleared 510(K)
- K123482REFLOW ASPIRATION CATHETER2Cleared 510(K)
- K120508CLEARLUMEN THROMBECTOMY SYSTEM2Cleared 510(K)
- K121301XPRESSWAY RX CATHETER (6F LD-VERISON)2Cleared 510(K)
- K120808EXPORT XT CATHETER, EXPORT AP CATHETER2Cleared 510(K)
- K113363ANGIOJET SOLENT DISTA THROMBECTOMY SET2Cleared 510(K)
- K113757ASPIRE MAX ASPIRATION CATHETER2Cleared 510(K)
- K112382TERUMO ASPRIATION CATHETER2Cleared 510(K)
- K113428ANGIOJET ULTRA DVX THROMBECTOMY SET2Cleared 510(K)
- K110315NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE2Cleared 510(K)
- K112571XL EXTRACTION CATHETER2Cleared 510(K)
- K111182ANGIOJET SOLENT OMNI THROMBECTOMY SET2Cleared 510(K)
- K100569MERIT EMBOLECTOMY CATHETER MODEL ASAP1002Cleared 510(K)
- K101354FETCH 2 ASPIRATION CATHETER MODEL 109400-0012Cleared 510(K)
- K103405PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH2Cleared 510(K)
- K101839KANEKA PHARMA AMERICA XPRESS-WAY RX2Cleared 510(K)
- K101406ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-0012Cleared 510(K)
- K091703HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 901312Cleared 510(K)
- K091593ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS2Cleared 510(K)
- K090253ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-0012Cleared 510(K)
- K083784PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER,2Cleared 510(K)
- K082382ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 1050392Cleared 510(K)
- K081989MODIFICATION TO FETCH ASPIRATION CATHETER2Cleared 510(K)
- K080806ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 1066082Cleared 510(K)
- K073519QUICKCAT EXTRACTION CATHETER, MODEL 60090-012Cleared 510(K)
- K073627FLEXOR EVAC ASPIRATION CATHETER2Cleared 510(K)
- K073441ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 1050392Cleared 510(K)
- K072810PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 50102Cleared 510(K)
- K072769ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS2Cleared 510(K)
- K071826THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG089102Cleared 510(K)
- K071727QXT EXTRACTION CATHETER2Cleared 510(K)
- K072269ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 1065522Cleared 510(K)
- K071336ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 1043072Cleared 510(K)
- K071529XTRACT CATHETER SYSTEM2Cleared 510(K)
- K071514ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 1043072Cleared 510(K)
- K071342ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 1050392Cleared 510(K)
- K070403PRONTO .035 EXTRACTION CATHETER2Cleared 510(K)
- K070363FETCH ASPIRATION CATHETER2Cleared 510(K)
- K063371PRONTO V3 EXTRACTION CATHETER, MODEL 50032Cleared 510(K)
- K061951ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 1202Cleared 510(K)
- K062275RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P701352Cleared 510(K)
- K062172FETCH ASPIRATION CATHETER2Cleared 510(K)
- K061958MEDTRONIC EXPORT XT CATHETER2Cleared 510(K)
- K053372LBI CATHETER SYSTEM2Cleared 510(K)
- K060092QUICKCAT EXTRACTION CATHETER2Cleared 510(K)
- K051880RIO ASPIRATION CATHETER2Cleared 510(K)
- K052256ANGIOJET XPEEDIOR 120 CATHETER2Cleared 510(K)
- K052232VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER2Cleared 510(K)
- K051917DIVER C.E. CATHETER2Cleared 510(K)
- K051193VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER2Cleared 510(K)
- K050130KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM2Cleared 510(K)
- K050794ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER2Cleared 510(K)
- K050139MODIFICATION TO: EXPORT CATHETER2Cleared 510(K)
- K050276DIVER C.E. CATHETER2Cleared 510(K)
- K042937MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER2Cleared 510(K)
- K042874ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX)2Cleared 510(K)
- K040869EXPORT CATHETER2Cleared 510(K)
- K040013ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY ANCILLARY KIT2Cleared 510(K)
- K032763VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER2Cleared 510(K)
- K972610POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C2Cleared 510(K)
- K9907716F HYDROLYSER THROMBECTOMY CATHETER2Cleared 510(K)
- K990805MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER2Cleared 510(K)
- K9835347F HYDROLYSER THROMBECTOMY CATHETER2Cleared 510(K)
- QLZSeptostomy Catheter, Reprocessed2Product Code
- QMSAdjunctive Open Loop Fluid Therapy Recommender2Product Code
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
KANEKA PHARMA AMERICA XPRESS-WAY RX
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K101839
- 510(k) Type
- Traditional
- Applicant
- Kaneka Pharma America, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/22/2010
- Days to Decision
- 113 days
- Submission Type
- Statement