ClearanceBrief
510(k) K093469 ยท JOH Tube Tracheostomy And Tube Cuff

CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS

ApplicantCook, Inc., Bloomington IN, US
DecisionSubstantially Equivalent, Jan 8, 2010
ReceivedNov 6, 2009
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K093469

DateFirm and productCodeLinked 510(k)
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-A-HC-PERC8, G12403.
Terminated
JOHNone listed
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTISY-100-A-HC-PERC8, G12566.
Terminated
JOHNone listed
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-HC-PERC6, G13165.
Terminated
JOHNone listed
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-HC-PERC6-CA, G36037.
Terminated
JOHNone listed
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTISY-100-HC-PERC6, G13166.
Terminated
JOHNone listed
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-HC-PERC8, G12523.
Terminated
JOHNone listed
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-HC-PERC8-CA, G36038.
Terminated
JOHNone listed
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTISY-100-HC-PERC8, G12565.
Terminated
JOHNone listed
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTISY-100-HC-G-PERC6, G53178.
Terminated
JOHNone listed
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-WCE-HC-G-PERC6, G53169.
Terminated
JOHNone listed
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-WCE-HC-G-PERC8, G53170.
Terminated
JOHNone listed
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G36116, C-PTBS-2600-PERC6.
Terminated
JOHNone listed
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G36118, C-PTBSY-2600-PERC6.
Terminated
JOHNone listed
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G51971, C-PTBSYJC-2600-PERC6.
Terminated
JOHNone listed
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G36117, C-PTBS-2800-PERC8.
Terminated
JOHNone listed
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G49507, C-PTBSY-2800-PERC8.
Terminated
JOHNone listed
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G51972, C-PTBSYJC-2800-PERC8.
Terminated
JOHNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.