DYB
CATHETER INTRODUCER
- Advisory panel
- Cardiovascular
- Total cleared
- 697
Adverse events under product code DYB
product code DYB- Death
- 808
- Injury
- 5,922
- Malfunction
- 16,516
- Other
- 5
- Total
- 23,251
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code DYB
1–100 of 697- K260839 — Protaryx Transseptal Puncture Device (PTX2-001)
- K260942 — AuST Steerable Sheath
- K260459 — VANES Delivery System (VDS)
- K260626 — Multiflex Steerable Sheath 17.5F
- K260163 — AuST CSP Introducer
- K254236 — Peel-Away Introducer Sheath
- K253652 — Genie MAX Large Bore Introducer Sheath
- K252508 — Intri26 Introducer Sheath
- K253741 — VStick Vascular Access Set
- K252309 — PerQseal Introducers
- K251838 — Introducer Sheath Set
- K252766 — 14Fr Low Profile Introducer Kit
- K252441 — Primero Safe Access System
- K252227 — Pounce(TM) Sheath
- K252027 — Vertex(TM) Catheter
- K252364 — Edwards eSheath Optima introducer set
- K251051 — AuST Steerable Sheath
- K250909 — Prelude Wave Hydrophilic Sheath Introducer
- K243954 — PeriCross Epicardial Access Kit
- K244046 — Edwards eSheath Optima introducer set
- K243928 — ViaOne Epicardial Access System
- K250468 — iSLEEVE Introducer Set
- K250439 — Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca
- K243493 — Agilis NxT Steerable Introducer Dual-Reach
- K242520 — Element Vascular Access System
- K242756 — Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)
- K243061 — SonoStik Guide Wire Introducer
- K242106 — AuST Steerable Sheath
- K241230 — Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008
- K240600 — SafeCross Vascular Introducer System (4001)
- K242169 — Morph DNA Steerable Introducer Sheath
- K242248 — Introducer Sheath Kits
- K240957 — Catapult Guide Sheath
- K241708 — Abiomed 14Fr Low Profile Introducer Kit
- K241145 — TLAB® Transvenous Liver Biopsy System (TF-18C)
- K241370 — Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED)
- K240829 — AuST Steerable Sheath
- K240589 — Micropuncture Introducer Sets; Micropuncture Pedal Access Sets
- K233708 — NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)
- K233959 — EPi-Ease Epicardial Access Device (EAS)
- K240004 — CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve Steer
- K231227 — SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath
- K233691 — FlexCath Cross Transseptal Solution
- K233646 — Intri24 Introducer Sheath (52-101)
- K233432 — 10F Sheath and Dilator Set
- K233503 — 14F iSLEEVE Introducer Set
- K231108 — Talon Transseptal Sheath
- K232260 — Thinline Sheath Introducer
- K231828 — Pounce Sheath
- K231412 — CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)
- K230631 — Kodiak Dual Port Coaxial Introducer Kit
- K230704 — RAIN Sheath Tibial Pedal Introducer
- K230283 — Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428)
- K222184 — Introducer Sheath Kits
- K230051 — 14F iSLEEVE Introducer Set
- K223872 — Low Profile Companion Sheath
- K221655 — Multiflex Steerable Sheath
- K222113 — Abiomed 14Fr Low Profile Introducer Set
- K221914 — Catapult Guide Sheath
- K213582 — Epicardial Access System
- K221440 — Liverty TIPS Access Set
- K220414 — VersaCross Connect Transseptal Dilator
- K220604 — EXTesia Introducer Sheath Set
- K212392 — Intri24 Sheath
- K213492 — Dib UltraNav Transseptal Catheter System
- K212626 — PathBuilder Transseptal Guiding Introducer
- K211530 — PathBuilder Steerable Introducer
- K220047 — AcQCross Qx Integrated Transseptal Dilator/Needle
- K212152 — Prelude IDeal 9F Hydrophilic Sheath Introducer
- K213638 — Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003)
- K213002 — SCORPION Portal Vein Access Set
- K211405 — Prelude Guide Sheath
- K212708 — Halo One Thin-Walled Guiding Sheath
- K211989 — Aveir Introducer
- K210185 — CardioCurve Steerable Sheath
- K203459 — SafeCross Transseptal Puncture and Introducer (TSP/I) System
- K210627 — Breezeway II
- K210685 — AcQCross Qx Integrated Transseptal Dilator/Needle
- K202167 — Brite Tip Radianz Guiding Sheath
- K203670 — Extra Large Check-Flo Introducer
- K202141 — Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set
- K201489 — Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set
- K202226 — Lim Precision Steerable TS, Steerable Sheath, Dilator
- K202330 — Impella XR Sheath Set
- K203179 — Fortress Introducer Sheath System
- K202584 — iSleeve Introducer Set
- K201116 — Abiomed 23 Fr Sheath
- K200258 — Edwards eSheath Introducer Set
- K193509 — AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX
- K193125 — R2P Destination Slender Guiding Sheath
- K192313 — Halo One Thin-Walled Guiding Sheath
- K193160 — Glidesheath Slender Tibial Pedal Kit
- K192769 — Impella CP Introducer
- K192106 — AcQRef Introducer Sheath
- K191871 — 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
- K191546 — Epicardial Access System
- K191190 — Steerable Introducer
- K183066 — The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD Technology-3 Fr, 4 Fr, and 5 Fr Model
- K190628 — FlexSeal Introducer Sheath with Hydrophilic Coating
- K183655 — VersaCross Transseptal Sheath
Data sourced from openFDA. This site is unofficial and independent of the FDA.