Product code DYB— Cardiovascular
CATHETER INTRODUCER
- Advisory panel
- Cardiovascular
- Total cleared
- 705
Clearances under product code DYB — page 4
301–400 of 705- K092097 — A.B. KORKOR MEDICAL SKINNYSAFE INTRODUCER SHEATH
- K100615 — ARSTASIS ACCESS SYSTEM
- K093791 — GORE DRYSEAL SHEATH
- K093232 — OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER
- K091006 — ITG VASCULAR ACCESS SYSTEM, MODEL 300
- K093026 — FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER
- K093022 — THE PICC WAND PEELABLE SAFETY INTRODUCER
- K091954 — MICRO-STICK SET
- K091367 — GDS-DCS
- K093130 — ENGAGE TR INTRODUCER
- K093023 — PTFE PEELABLE INTRODUCER
- K092014 — SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
- K092575 — ENGAGE/ENGAGE TR
- K090394 — VALVED TEARWAY INTRODUCER
- K090867 — AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002
- K090114 — MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S
- K091329 — PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
- K091137 — ULTIMUM/ENGAGE/ENGAGE TR
- K090999 — BIOCARDIA MORPH SHEATH GUIDE
- K090372 — THE WAND MICROACCESS SAFETY INTRODUCER
- K083855 — MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59
- K083269 — CROSSOVER
- K083402 — AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323
- K081645 — AGILIS NXT STEERABLE INTRODUCER, MODEL G408324
- K082580 — SPECTRA GUIDEWIRE INTRODUCER NEEDLE
- K081697 — THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006
- K083083 — AGILIS NXT STEERABLE INTRODUCER
- K082847 — PINNACLE ROII INTRODUCER SHEATH
- K082063 — PRELUDE SHORT SHEATH INTRODUCER
- K082644 — GLIDESHEATH
- K081394 — PTFE INTERLOCK PEELABLE INTRODUCERS
- K082356 — GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
- K081045 — DESTINATION RENAL GUIDING SHEATH
- K081046 — PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
- K081341 — REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)
- K073434 — BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
- K080500 — MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7
- K072719 — CONVOY ADVANCED DELIVERY SHEATH
- K080415 — DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
- K073100 — INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S
- K072248 — VIAPEEL PEELABLE INTRODUCER
- K072130 — PTFE PEEL AWAY MICROINTRODUCER
- K070865 — EXPANDING VASCULAR SHEATH
- K070816 — PERIPHERAL GUIDING SHEATH
- K063658 — INTRAVASCULAR INTRODUCER SYSTEM
- K071574 — STIFFER COAXIAL MICRO-INTRODUCER KIT
- K070417 — ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984
- K070396 — MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45
- K070166 — STRADA CAROTID GUIDING SHEATH
- K062852 — BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870
- K070197 — ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY
- K063182 — ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX
- K062446 — MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH
- K062858 — MODIFICATION TO GLIDESHEATH
- K062145 — MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90
- K061015 — FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER
- K053092 — MEDCOMP VASCU-SHEATH II
- K061363 — AGILIS NXT STEERABLE INTRODUCER
- K060902 — STARCLOSE INTRODUCER SET MODEL- 1002
- K060666 — CAROTID ACCESS KIT
- K053400 — ACUMEN SINGLE-LUMEN DELIVERY SHEATH
- K060519 — INTRODUCER ASSEMBLY WITH ROTATOR LOCK
- K060190 — SUPER SHEATH XL INTRODUCER SHEATH
- K051513 — BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
- K052644 — SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER
- K051248 — VYGON MICRO-ACCESS SAFETY INTRODUCER KIT
- K052185 — DESTINATION CAROTID GUIDING SHEATH
- K051515 — MODIFIED ACUMEN SHEATH, MODEL TTW 10-65
- K051468 — INNER-LOCK INTRODUCER SHEATH
- K051601 — PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
- K051096 — APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582
- K043084 — PREMERE DELIVERY SHEATH, MODEL PDS
- K050023 — SECURELOC; ADVANCINTRODUCER
- K042308 — SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S00019
- K043438 — LARGE BORE SPLITTABLE INTRODUCER KIT
- K043525 — CATHETER INTRODUCER
- K050015 — MODIFIED ACUMEN SHEATH, MODEL TTWO767
- K042623 — AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304
- K042399 — MODIFICATION TO SHORT INTRODUCER SHEATH
- K041708 — ENPATH SAFETY INTRODUCER
- K042376 — ACUMEN SHEATH, MODEL TTW7807
- K041506 — INTRAVASCULAR ACCESS INTRODUCER SHEATH
- K042036 — AIRGUARD VALVED INTRODUCER
- K040728 — ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT
- K040713 — MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM
- K040552 — MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130
- K040029 — SAFETYNET GUIDEWIRE INTRODUCER
- K034025 — NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC
- K040150 — MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER
- K033527 — INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER
- K034061 — MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH
- K033681 — GLIDESHEATH
- K031922 — CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W
- K032569 — SHORT INTRODUCER SHEATH
- K030734 — PATHWAY ACCESS SHEATH CATHETER
- K032404 — SELDINGER SAFETY NEEDLE INTRODUCER
- K032073 — GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
- K031906 — APEEL CS CATHETER DELIVERY SYSTEM
- K030135 — SAFETY INTRODUCER NEEDLE
- K030944 — EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
Data sourced from openFDA. This site is unofficial and independent of the FDA.