Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- MOFGuide, Wire, Catheter, Neurovasculature2Product Code
- NDQSystem, Catheter Or Guidewire, Steerable (Magnetic)2Product Code
- NRYCatheter, Thrombus Retriever2Product Code
- K252046Zoom System (Zoom 4S Catheter)2Cleared 510(K)
- K251603Tigertriever 17 Ultra Revascularization Device2Cleared 510(K)
- K251789EMBOTRAP III Revascularization Device2Cleared 510(K)
- K252392Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set2Cleared 510(K)
- K251828CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set2Cleared 510(K)
- K243948Raptor Aspiration Catheter; Balt Aspiration Tubing Set2Cleared 510(K)
- K243047Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing2Cleared 510(K)
- K243601Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set2Cleared 510(K)
- K251015APRO 45 Catheter and Alembic Aspiration Tubing2Cleared 510(K)
- K250958APRO 55 Swift Catheter and Alembic Aspiration Tubing2Cleared 510(K)
- K250012Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set2Cleared 510(K)
- K243287APRO 70 Swift Catheter and Alembic Aspiration Tubing2Cleared 510(K)
- K242104Penumbra System (Reperfusion Catheter RED 72)2Cleared 510(K)
- K242672Zoom System2Cleared 510(K)
- K243080Riptide Aspiration System2Cleared 510(K)
- K241221CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set2Cleared 510(K)
- K240917Esperance 3+ Aspiration Catheter System2Cleared 510(K)
- K242504Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set2Cleared 510(K)
- K234083Next Generation Aspiration Catheter; Balt Aspiration Tubing Set2Cleared 510(K)
- K233329Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set2Cleared 510(K)
- K232971APRO 55 Catheter and Alembic Aspiration Tubing2Cleared 510(K)
- K233988Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set2Cleared 510(K)
- K232524Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set2Cleared 510(K)
- K223913Socrates Aspiration System2Cleared 510(K)
- K222786072 Aspiration System2Cleared 510(K)
- K230429Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device2Cleared 510(K)
- K223530Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set2Cleared 510(K)
- K230695APRO 70 Catheter and Alembic Aspiration Tubing2Cleared 510(K)
- K221934CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set2Cleared 510(K)
- K223545APRO 70 Catheter and Alembic Aspiration Tubing2Cleared 510(K)
- K222808Penumbra System (Reperfusion Catheter RED 43)2Cleared 510(K)
- K220808Tigertriever 13 Revascularization Device2Cleared 510(K)
- K211120ERIC Retrieval Device2Cleared 510(K)
- K211697Esperance Aspiration Catheter System2Cleared 510(K)
- K212908EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device2Cleared 510(K)
- K211654Penumbra System (Reperfusion Catheter RED 72)2Cleared 510(K)
- K211338EMBOTRAP III Revascularization Device2Cleared 510(K)
- K211411Penumbra System (RED 68 Reperfusion Catheter)2Cleared 510(K)
- K211476ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing2Cleared 510(K)
- K203440Penumbra System (Reperfusion Catheter RED 62)2Cleared 510(K)
- K210996ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing2Cleared 510(K)
- K203592Tigertriever and Tigertriever 17 Revascularization Devce2Cleared 510(K)
- K202182ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing2Cleared 510(K)
- K202251Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)2Cleared 510(K)
- K201689Riptide Aspiration System2Cleared 510(K)
- K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set2Cleared 510(K)
- K193063EMBOTRAP III Revascularization Device2Cleared 510(K)
- K191946Penumbra System Penumbra JET 7X2Cleared 510(K)
- K190338046 Zenith Flex2Cleared 510(K)
- K191768AXS Vecta Aspiration System2Cleared 510(K)
- K190010Penumbra System Reperfusion Catheter JET 72Cleared 510(K)
- K190464Penumbra System 3D Revascularization Device2Cleared 510(K)
- K190212AXS Vecta Aspiration System2Cleared 510(K)
- K1830430.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter2Cleared 510(K)
- K183464AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)2Cleared 510(K)
- K183185Riptide Aspiration System (Riptide Large Bore Aspiration System)2Cleared 510(K)
- K182101Riptide Aspiration System (React 71 Catheter)2Cleared 510(K)
- K181354074 Zenith Flex System2Cleared 510(K)
- K182522Penumbra System (Modified 110 Aspiration Tubing)2Cleared 510(K)
- K173761Penumbra System Reperfusion Catheter JET 72Cleared 510(K)
- K180705Riptide Aspiration System React 68 Catheter2Cleared 510(K)
- K180008Penumbra System2Cleared 510(K)
- K173200SOFIA Plus Aspiration Catheter2Cleared 510(K)
- K173452EmboTrap ll Revascularization Device2Cleared 510(K)
- K172167Zenith Flex System2Cleared 510(K)
- K173841AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm2Cleared 510(K)
- K172448Riptide Aspiration System2Cleared 510(K)
- K162901Penumbra 3D Revascularization Device2Cleared 510(K)
- K160641Solitaire Platinum Revascularization Device, 6x40 mm2Cleared 510(K)
- K161879Solitaire Platinum Revascularization Device2Cleared 510(K)
- K161640Penumbra System ACE 68 Reperfusion Catheter2Cleared 510(K)
- K161064Penumbra System ACE 68 Reperfusion Catheter2Cleared 510(K)
- K160449Penumbra System, Penumbra Pump MAX2Cleared 510(K)
- K152541Penumbra System ACE 64 and ACE 68 Reperfusion Catheters2Cleared 510(K)
- K153071Solitaire Platinum Revascularization Device2Cleared 510(K)
- K151623Penumbra System 110 Aspiration Tubing2Cleared 510(K)
- K150616Trevo XP ProVue Retriever (4x30mm)2Cleared 510(K)
- K142458Penumbra System ACE2Cleared 510(K)
- K143077Trevo XP ProVue Retriever (6X25mm)2Cleared 510(K)
- K141516MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE2Cleared 510(K)
- K141491SOLITAIRE 2 REVASCULARIZATION DEVICE2Cleared 510(K)
- K133317PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX2Cleared 510(K)
- K133464MODIFIED TREVO PROVUE RETRIEVER2Cleared 510(K)
- K132641MODIFIED TREVO PROVUE RETRIEVER2Cleared 510(K)
- K123378SOLITAIRE 2 REVASCULARIZATION DEVICE2Cleared 510(K)
- K122478MODIFIED TREVO RETRIEVER2Cleared 510(K)
- K120961TREVO RETRIEVER2Cleared 510(K)
- K113455SOLITAIRE FR REVASCULARIZATION DEVICE2Cleared 510(K)
- K113163PENUMBRA SYSTEM MAX2Cleared 510(K)
- K093610MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 901532Cleared 510(K)
- K100769PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF0542Cleared 510(K)
- K090752PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS0542Cleared 510(K)
- K090085MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 901132Cleared 510(K)
- K082034MODIFICATION TO MERCI RETRIEVER2Cleared 510(K)
- K081305MERCI RETRIEVER2Cleared 510(K)
- K072718PENUMBRA SYSTEM2Cleared 510(K)
- K071172MODIFIED MERCI RETRIEVER, MODEL 900602Cleared 510(K)
- K070521MODIFIED MERCY RETRIEVER, MODEL 900702Cleared 510(K)
- K063774MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X62Cleared 510(K)
- K062046MODIFIED MERCI RETRIEVER, MODEL 900502Cleared 510(K)
- K061059MODIFIED MERCI RETRIEVER, MODEL 900922Cleared 510(K)
- K033736MERCI RETRIEVER, MODELS 90065, 900662Cleared 510(K)
- NUIUltrasound, Infusion, System2Product Code
- QBECranial Sound Monitor2Product Code
- QJPCatheter, Percutaneous, Neurovasculature2Product Code
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- 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
046 Zenith Flex
- Page Type
- Cleared 510(K)
- 510(k) Number
- K190338
- 510(k) Type
- Traditional
- Applicant
- InNeuroCo, Inc
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/2/2019
- Days to Decision
- 169 days
- Submission Type
- Summary