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
- K241851Versus™ Catheter (VS110-8B)2Cleared 510(K)
- K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter2Cleared 510(K)
- K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 71012Cleared 510(K)
- K220866EKOS+ Endovascular Device2Cleared 510(K)
- K213422EkoSonic Endovascular Device, EKOS+ Endovascular Device2Cleared 510(K)
- K211080EkoSonic Endovascular Device2Cleared 510(K)
- K211061BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240)2Cleared 510(K)
- K202347UNIFUSE Infusion System with Cooper Wire2Cleared 510(K)
- K200648EKOS PE Endovascular Device with Control System 4.0 (CS4.0)2Cleared 510(K)
- K192864UNI*FUSE Infusion System with Cooper Wire2Cleared 510(K)
- K193071Bashir Plus Endovascular Catheter2Cleared 510(K)
- K192598Bashir S-B Endovascular Catheter, Ref. No. 71012Cleared 510(K)
- K191119EkoSonic Endovascular Device2Cleared 510(K)
- K183361EkoSonic Endovascular Device with Control Unit 4.02Cleared 510(K)
- K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 72002Cleared 510(K)
- K182324EkoSonic Endovascular System2Cleared 510(K)
- K163356Pulse* Spray Infusion System, Uni*Fuse Infusion System2Cleared 510(K)
- K162771EkoSonic Endovascular System with Control Unit 4.02Cleared 510(K)
- K170258SpeedLyser Infusion Catheter Kit2Cleared 510(K)
- K162777Squirt Fluid Delivery System2Cleared 510(K)
- K153488Occlusion Perfusion Catheter2Cleared 510(K)
- K151554Occlusion Perfusion Catheter2Cleared 510(K)
- K140151EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT2Cleared 510(K)
- K130904TRELLIS-8 PERIPHERAL INFUSION SYSTEM2Cleared 510(K)
- K111705EKOSONIC ENDOVASCULAR SYSTEM2Cleared 510(K)
- K083335MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM2Cleared 510(K)
- K082199SPIRALFUSE PERIPHERAL INFUSION SYSTEM2Cleared 510(K)
- K081467EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION2Cleared 510(K)
- K080392EndoWave Infusion System2Cleared 510(K)
- K072507ENDOWAVE INFUSION SYSTEM2Cleared 510(K)
- K071762OMNIWAVE ENDOVASCULAR SYSTEM2Cleared 510(K)
- K071933ENDOWAVE INFUSION SYSTEM2Cleared 510(K)
- K063620EKOS MICRO-INFUSION SYSTEM2Cleared 510(K)
- K071664TRELLIS-6 PERIPHERAL INFUSION SYSTEM2Cleared 510(K)
- K062507MICRO-INFUSION SYSTEM2Cleared 510(K)
- K060422LYSUS INFUSION SYSTEM2Cleared 510(K)
- K060084LYSUS INFUSION SYSTEM2Cleared 510(K)
- K053432EKOS MICRO-INFUSION SYSTEM2Cleared 510(K)
- K052428RESOLUTION ENDOVASCULAR SYSTEM2Cleared 510(K)
- K052071LYSUS INFUSION SYSTEM2Cleared 510(K)
- K051319LYSUS INFUSION SYSTEM2Cleared 510(K)
- K050563EKOS PERIPHERAL INFUSION SYSTEM2Cleared 510(K)
- K050147TRELLIS-8 PERIPHERAL INFUSION SYSTEM2Cleared 510(K)
- K043269Lysus Infusion System2Cleared 510(K)
- K042456Lysus Infusion System2Cleared 510(K)
- K041705RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-22Cleared 510(K)
- K041629LYSUS INFUSION SYSTEM2Cleared 510(K)
- K041517INFUSIONCATH2Cleared 510(K)
- K033443SPEEDLYSER INFUSION CATHETER KIT2Cleared 510(K)
- K033214EKOS PERIPHERAL INFUSION SYSTEM2Cleared 510(K)
- K032261Trellis Reserve Infusion System2Cleared 510(K)
- K030637EKOS PERIPHERAL INFUSION SYSTEM2Cleared 510(K)
- K023514TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH)2Cleared 510(K)
- K021958TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH 20CM (100CM CATHETER LENGTH 10CM INFUSION H2Cleared 510(K)
- K013635TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION SYSTEM (20CM INFUSION LENGTH)2Cleared 510(K)
- K992231FOUNTAIN Infusion Catheter and Occluding Guide Wire2Cleared 510(K)
- K991619FOUNTAIN Infusion Catheter and Occluding Guide Wire2Cleared 510(K)
- K981417Squirt Fluid Delivery System2Cleared 510(K)
- K980957KAPLAN-SIMPSON INFUSASLEEVE II2Cleared 510(K)
- K974067FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE2Cleared 510(K)
- K972175INFUSASLEEVE IIA (IS-2A)2Cleared 510(K)
- K972110Cordis Endeavor Infusion Catheter2Cleared 510(K)
- K970842Cordis Endeavor Infusion Catheter2Cleared 510(K)
- K961763PULSE*SPRAY INFUSION SYSTEM2Cleared 510(K)
- QEZAspiration Thrombectomy Catheter2Product Code
- QLZSeptostomy Catheter, Reprocessed2Product Code
- QMSAdjunctive Open Loop Fluid Therapy Recommender2Product Code
- Subpart F—Therapeutic DevicesCFR Sub-Part
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- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
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- UnknownReview Panel
EkoSonic Endovascular Device
- Page Type
- Cleared 510(K)
- 510(k) Number
- K191119
- 510(k) Type
- Special
- Applicant
- BTG International, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/23/2019
- Days to Decision
- 119 days
- Submission Type
- Summary