Anesthesiology
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- 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
- NUIUltrasound, Infusion, System2Product Code
- QBECranial Sound Monitor2Product Code
- QJPCatheter, Percutaneous, Neurovasculature2Product Code
- K251372VersaD Delivery Catheter2Cleared 510(K)
- K252569Carrier XL Delivery Catheter2Cleared 510(K)
- K250960DUO Microcatheter2Cleared 510(K)
- K251560FUBUKI XF-R Neurovascular Long Sheath2Cleared 510(K)
- K251240Branchor X Balloon Guide Catheter2Cleared 510(K)
- K25104493 NeuFlex Catheter2Cleared 510(K)
- K242392PATH BGC2Cleared 510(K)
- K242289Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter2Cleared 510(K)
- K243593AXS Lift Intracranial Base Catheter2Cleared 510(K)
- K242051VersaD Delivery Catheter2Cleared 510(K)
- K243577Radical the Dude 8F Guide Catheter2Cleared 510(K)
- K243297APRO 70 Swift Catheter2Cleared 510(K)
- K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter2Cleared 510(K)
- K242376Next Generation Access Platform2Cleared 510(K)
- K241768Broadway 8 Catheter2Cleared 510(K)
- K241637Echo Intracranial Base Catheter2Cleared 510(K)
- K242033Access25™ Delivery Microcatheter2Cleared 510(K)
- K24097187 NeuGlide Catheter2Cleared 510(K)
- K242301Socrates 38 Catheter2Cleared 510(K)
- K240746Neurovascular Access System Family2Cleared 510(K)
- K240711Zipline Access Catheter2Cleared 510(K)
- K241244CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter2Cleared 510(K)
- K2405298F Modified Sheath System2Cleared 510(K)
- K234074Next Generation Access Catheter2Cleared 510(K)
- K240948TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support2Cleared 510(K)
- K232542Wedge XL Delivery Catheter2Cleared 510(K)
- K233982CEREGLIDE 92 Catheter System2Cleared 510(K)
- K233924EMBOGUARD Balloon Guide Catheter2Cleared 510(K)
- K233201MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)2Cleared 510(K)
- K231056Esperance Distal Access Catheter2Cleared 510(K)
- K231218Distal Access Catheter2Cleared 510(K)
- K233205Distal Access Catheter2Cleared 510(K)
- K233648Millipede 088 Access Catheter2Cleared 510(K)
- K231179Slinky Catheter2Cleared 510(K)
- K231393Radical the Dude 7F Guide Catheter2Cleared 510(K)
- K230726CEREGLIDE 92 Intermediate Catheter2Cleared 510(K)
- K231802Millipede 088 Access Catheter2Cleared 510(K)
- K222948Q Distal Access Catheter2Cleared 510(K)
- K230775SOFIA EX Intracranial Support Catheter2Cleared 510(K)
- K230609NG Delivery Catheter2Cleared 510(K)
- K223560Plato 17 Microcatheter2Cleared 510(K)
- K231583Route 92 Medical Full Length 054 Access System2Cleared 510(K)
- K230322SelectFlex Neurovascular Access System Family2Cleared 510(K)
- K231168TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support2Cleared 510(K)
- K221930CEREGLIDE 71 Intermediate Catheter2Cleared 510(K)
- K223275CELLO II Balloon Guide Catheter2Cleared 510(K)
- K221822BENCHMARK BMX81 Access System2Cleared 510(K)
- K221951Branchor Balloon Guide Catheter2Cleared 510(K)
- K222743Route 92 Medical Full Length 070 Access System2Cleared 510(K)
- K214048Millipede 088 Access Catheter2Cleared 510(K)
- K213390Benchmark BMX96 Access System2Cleared 510(K)
- K212288Minjie Catheter System2Cleared 510(K)
- K213065Distal Access Catheter2Cleared 510(K)
- K212838Benchmark Intracranial Access System2Cleared 510(K)
- K220807Imperative Care Radial 088 Access System2Cleared 510(K)
- K203842Bendit21 Microcatheter2Cleared 510(K)
- K213589FUBUKI XF Neurovascular Long Sheath2Cleared 510(K)
- K213314CerusEndo Microcatheter (027)2Cleared 510(K)
- K202926Micro Catheter2Cleared 510(K)
- K212340EMBOGUARD Balloon Guide Catheter2Cleared 510(K)
- K212402MIVI Q Distal Access Catheter2Cleared 510(K)
- K203723Branchor Balloon Guide Catheter2Cleared 510(K)
- K211594Trevo Trak 21 Microcatheter2Cleared 510(K)
- K213451Spartan MC 01652Cleared 510(K)
- K212224TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform2Cleared 510(K)
- K202752AXS Vecta 46 Intermediate Catheter2Cleared 510(K)
- K202916Balloon Guiding Catheter2Cleared 510(K)
- K211893SelectFlex Neurovascular Access System Family2Cleared 510(K)
- K210635Route 92 Medical Full Length 088 Access System2Cleared 510(K)
- K203764TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform2Cleared 510(K)
- K203840BOSS 8F Balloon Guide Catheter2Cleared 510(K)
- K203043Route 92 Medical 070 Access System2Cleared 510(K)
- K201682RIST Radial Access Catheter2Cleared 510(K)
- K201518Route 92 Medical 088 Access System2Cleared 510(K)
- K201076Anchor Dual Lumen Guidewire Catheter2Cleared 510(K)
- K200910BOSS Balloon Guide Catheter2Cleared 510(K)
- K200417RIST Radial Access Catheter2Cleared 510(K)
- K200121Route 92 Medical 088 Access System, 110 cm2Cleared 510(K)
- K200206AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter2Cleared 510(K)
- K192804CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm2Cleared 510(K)
- 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
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8F Modified Sheath System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K240529
- 510(k) Type
- Special
- Applicant
- Route 92 Medical, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/2/2024
- Days to Decision
- 222 days
- Submission Type
- Summary