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
- K253323Protrieve Sheath2Cleared 510(K)
- K251185Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)2Cleared 510(K)
- K252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing2Cleared 510(K)
- K252057Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System2Cleared 510(K)
- K251485Excipio LV Prime Thrombectomy Device2Cleared 510(K)
- K251189Aventus Thrombectomy System2Cleared 510(K)
- K250787Liberant Thrombectomy System2Cleared 510(K)
- K250775Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System2Cleared 510(K)
- K250421InThrill™ Thrombectomy System2Cleared 510(K)
- K250668Aventus Thrombectomy System (IM-2100)2Cleared 510(K)
- K250668Aventus Thrombectomy System (IM-2100)2Cleared 510(K)
- K250088FlowTriever2 Catheter2Cleared 510(K)
- K250202Aventus Thrombectomy System2Cleared 510(K)
- K241894Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath2Cleared 510(K)
- K242557ClotTriever XL Catheter (41-102)2Cleared 510(K)
- K242075Indigo® Aspiration System – Lightning Bolt Aspiration Tubing2Cleared 510(K)
- K241362Pounce XL Thrombectomy System (PTS-1011-7F135)2Cleared 510(K)
- K242319Indigo® Aspiration System – Aspiration Catheter 6X2Cleared 510(K)
- K233917ICHOR 7F Embolectomy System (ICH-7F)2Cleared 510(K)
- K241399Indigo® Lightning Flash Aspiration System – Select +™ Catheter2Cleared 510(K)
- K241207SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02)2Cleared 510(K)
- K234073ICE Aspiration System2Cleared 510(K)
- K233909Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister2Cleared 510(K)
- K240117Aventus Thrombectomy System (IM-2001/IM-0002)2Cleared 510(K)
- K234034VenaCore Thrombectomy Catheter (46-101)2Cleared 510(K)
- K240030Indigo® Aspiration System - Lightning® Flash2Cleared 510(K)
- K232679Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister2Cleared 510(K)
- K233815ClotTriever Sheath2Cleared 510(K)
- K232730Aventus Thrombectomy System2Cleared 510(K)
- K230743ICHOR 14F Embolectomy System2Cleared 510(K)
- K231848Triever20 Curve (21-201)2Cleared 510(K)
- K231022Pounce™ Thrombectomy System2Cleared 510(K)
- K223929Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System)2Cleared 510(K)
- K230030Excipio SV Aspiration Catheter and Tubing2Cleared 510(K)
- K230912Artix BG2Cleared 510(K)
- K223210ClotTriever XL Catheter2Cleared 510(K)
- K230494ClotTriever BOLD Catheter2Cleared 510(K)
- K230356Aspirex™ Thrombectomy System2Cleared 510(K)
- K220780ROVO Mechanical Thrombectomy Device2Cleared 510(K)
- K223419Triever16 Curve2Cleared 510(K)
- K223613InThrill Thrombectomy System2Cleared 510(K)
- K223609RevCore™ Thrombectomy Catheter.2Cleared 510(K)
- K230331Protrieve Sheath2Cleared 510(K)
- K223436Artix AX2Cleared 510(K)
- K223216Symphony Thrombectomy System2Cleared 510(K)
- K223897Excipio LV Thrombectomy Device2Cleared 510(K)
- K223891Cobra Catheter System2Cleared 510(K)
- K223186Indigo® Aspiration System – Lightning Bolt Aspiration Tubing2Cleared 510(K)
- K221531ClotTriever Thrombectomy System2Cleared 510(K)
- K223000Artix BG2Cleared 510(K)
- K222358Indigo Aspiration System - Lightning Flash2Cleared 510(K)
- K221391WOLF Thrombectomy™ SmartClaw Catheter2Cleared 510(K)
- K220683INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)2Cleared 510(K)
- K220887Mini-ClotTriever Thrombectomy System2Cleared 510(K)
- K220415Protrieve Sheath2Cleared 510(K)
- K221204Excipio SV Thrombectomy Device2Cleared 510(K)
- K220270Aspirex Thrombectomy System2Cleared 510(K)
- K213402Triever24, Triever202Cleared 510(K)
- K214114Prodigy Thrombectomy System2Cleared 510(K)
- K220600Artix Thrombectomy Device2Cleared 510(K)
- K220501Pounce Thrombectomy System2Cleared 510(K)
- K211798Cleaner Plus Thrombectomy System2Cleared 510(K)
- K210911WOLF Thrombectomy System, 14F2Cleared 510(K)
- K212632ClotTriever Thrombectomy System2Cleared 510(K)
- K210530WOLF Thrombectomy System, 6F2Cleared 510(K)
- K211492Pounce Thrombectomy System2Cleared 510(K)
- K210689ClotTriever Thrombectomy System2Cleared 510(K)
- K211013FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 242Cleared 510(K)
- K210323Indigo Aspiration System - Lightning Aspiration Tubing2Cleared 510(K)
- K210195Triever Catheters2Cleared 510(K)
- K210190ClotTriever Thrombectomy System2Cleared 510(K)
- K210083Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 72Cleared 510(K)
- K201085NeVa PV Thrombectomy Device2Cleared 510(K)
- K203476CAPERE Thrombectomy System2Cleared 510(K)
- K201705ReVene Thrombectomy Catheter2Cleared 510(K)
- K202345FlowTriever Retrieval/Aspiration System2Cleared 510(K)
- K203333Triever20 Curve Catheter2Cleared 510(K)
- K201541FlowTriever Retrieval/Aspiration System2Cleared 510(K)
- K202821Indigo Aspiration System - Aspiration Catheter 12 and Separator 122Cleared 510(K)
- K202218ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device2Cleared 510(K)
- K192814Pounce Thrombus Retrieval System2Cleared 510(K)
- K193462ClotTriever Thrombectomy System2Cleared 510(K)
- K193595Indigo Aspiration System - Aspiration Catheter 7 and Separator 72Cleared 510(K)
- K201216CAPERE Thrombectomy System2Cleared 510(K)
- K192981Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 122Cleared 510(K)
- K200101WOLF Thrombectomy V System2Cleared 510(K)
- K200771Indigo Aspiration System Lightning Aspiration Tubing2Cleared 510(K)
- K193244Indigo Aspiration System – Lightning Aspiration Tubing2Cleared 510(K)
- K200314Capere Thrombectomy System2Cleared 510(K)
- K192833Indigo Aspiration System2Cleared 510(K)
- K192935CAPERE Thrombectomy System2Cleared 510(K)
- K192332ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath2Cleared 510(K)
- K191710FlowTriever Retrieval/Aspiration System2Cleared 510(K)
- K192036ClotTriever Thrombectomy System2Cleared 510(K)
- K191368FlowTriever Retrieval/Aspiration System2Cleared 510(K)
- K182835WOLF Thrombectomy Device2Cleared 510(K)
- K183179CAPERE Thrombectomy System2Cleared 510(K)
- K182167The ICHOR Panacea Vascular Embolectomy Catheter System2Cleared 510(K)
- K183198FlowTriever Retrieval/Aspiration System2Cleared 510(K)
- K182233FlowTriever Retrieval/Aspiration System2Cleared 510(K)
- K182531ClotTriever Thrombectomy System2Cleared 510(K)
- K181694FlowTriever Retrieval/Aspiration System2Cleared 510(K)
- K181325FlowTriever Retrieval/Aspiration System2Cleared 510(K)
- K180722CAPERE Thrombectomy System2Cleared 510(K)
- K180466FlowTriever Retrieval/Aspiration System2Cleared 510(K)
- K180412Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister2Cleared 510(K)
- K180939Indigo Aspiration System - Modified 110 Aspiration Tubing2Cleared 510(K)
- K180329ClotTriever Thrombectomy System2Cleared 510(K)
- K180105Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister2Cleared 510(K)
- K173672FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter2Cleared 510(K)
- K172716V2K Rinspiration System2Cleared 510(K)
- K173470ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath2Cleared 510(K)
- K163549ClotTriever Thrombectomy System2Cleared 510(K)
- K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator2Cleared 510(K)
- K161506Penumbra Aspiration System2Cleared 510(K)
- K161523INDIGO Aspiration System2Cleared 510(K)
- K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)2Cleared 510(K)
- K151313ZelanteDVT Thrombectomy Set2Cleared 510(K)
- K152097Retraction Aspirator2Cleared 510(K)
- K142870Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]2Cleared 510(K)
- K143563Infusion Aspiration Catheter System2Cleared 510(K)
- K141617CLEANER ROTATIONAL THROMBECTOMY SYSTEM2Cleared 510(K)
- K133629ANGIOJET ULTRA AVX THROMBECTOMY SET2Cleared 510(K)
- K132281ReVive PV (Peripheral Vasculature) Thrombectomy Device2Cleared 510(K)
- K130381ANGIOJET ULTRA POWER PULSE KIT2Cleared 510(K)
- K121917PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM2Cleared 510(K)
- K092623F.A.S.T. SYSTEM SED AND CXD2Cleared 510(K)
- K090932NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-20002Cleared 510(K)
- K083370D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 40062Cleared 510(K)
- K080901LBI EMBOLECTOMY SYSTEM2Cleared 510(K)
- K041374AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL100600602Cleared 510(K)
- K040010GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS2Cleared 510(K)
- K021641XTD THROMBECTOMY CATHETER, XX CM2Cleared 510(K)
- K011056ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD2Cleared 510(K)
- K991093MSD EMBOLECTOMY BASKET2Cleared 510(K)
- QEXCoronary Mechanical Thrombectomy With Aspiration2Product Code
- QEYMechanical Thrombolysis Catheter2Product Code
- QEZAspiration Thrombectomy Catheter2Product Code
- 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
Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)
- Page Type
- Cleared 510(K)
- 510(k) Number
- K160533
- 510(k) Type
- Traditional
- Applicant
- Penumbra, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/24/2016
- Days to Decision
- 96 days
- Submission Type
- Summary