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
- K242776LimFlow V-Ceiver2Cleared 510(K)
- K241259Amplatz Goose Neck Snare Kit2Cleared 510(K)
- K232443Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit2Cleared 510(K)
- K222254Gunther Tulip Vena Cava Filter Retrieval Set2Cleared 510(K)
- K222083LimFlow V-Ceiver2Cleared 510(K)
- K212988ONO Retrieval Device2Cleared 510(K)
- K213494Aveir Retrieval Catheter2Cleared 510(K)
- K200963Halo Single-Loop Microsnare Kit2Cleared 510(K)
- K200268Halo™ Single-Loop Snare Kit2Cleared 510(K)
- K193507Merit ONE Snare System2Cleared 510(K)
- K191758Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit2Cleared 510(K)
- K181757Günther Tulip® Vena Cava Filter Retrieval Set2Cleared 510(K)
- K170987Captus Vascular Retrieval System2Cleared 510(K)
- K163307Expro Elite Snare, Sympro Elite Snare2Cleared 510(K)
- K160593Indy OTW Vascular Retriever2Cleared 510(K)
- K152136Recovery Cone Removal System2Cleared 510(K)
- K152560Bard Snare Retrieval Kit2Cleared 510(K)
- K151497EN Snare Endovascular Snare System2Cleared 510(K)
- K142265ONE Snare Endovascular Microsnare System2Cleared 510(K)
- K133681CRUX SNARE FILTER RETRIEVAL SET2Cleared 510(K)
- K122088MERIT ONE SNARE SYSTEM2Cleared 510(K)
- K112185FOURSNARE VASCULAR RETRIEVAL SNARE2Cleared 510(K)
- K102484SEQURE SNARE SYSTEM2Cleared 510(K)
- K092343EN SNARE ENDOVASCULAR SNARE SYSTEM2Cleared 510(K)
- K091563RECRUIT MICROCATHETER2Cleared 510(K)
- K071457MODIFICATION TO RADIUS SNARE2Cleared 510(K)
- K050926TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX301200602Cleared 510(K)
- K033188TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX300600502Cleared 510(K)
- K022201RADIUS MICRO SNARE2Cleared 510(K)
- K021441RADIUS SNARE2Cleared 510(K)
- K021606EN-SNARE ENDOVASCULAR SNARE AND CATHETER2Cleared 510(K)
- K014109IN-TIME RETRIEVAL DEVICE2Cleared 510(K)
- 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
- 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
Indy OTW Vascular Retriever
- Page Type
- Cleared 510(K)
- 510(k) Number
- K160593
- 510(k) Type
- Traditional
- Applicant
- Cook Incorporated
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/2/2016
- Days to Decision
- 185 days
- Submission Type
- Summary