FDA.reportPublic FDA data

510(k) K901281

Device
Thermo Kor-continuous Pulmonary Artery Thermometer
Applicant
VAL-MARK MEDICAL, INC.
510(k) number
K901281
Product code
DRB
Decision
Substantially Equivalent (SESE)
Decision date
1991-08-28
Date received
1990-03-19
Regulation
870.1380
Classification name
Stylet, Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
STEVEN V BUSH
Address
115 W. Logan St. West St. Paul MN US 55118 55118

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DRB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220280Arrow Stiffening StyletArrow International, LLC (A subsidiary of Teleflex, Inc.)2022-08-30
K191469Biotronik StyletsBiotronik, Inc.2019-08-01
K182660GaltTWSGalt Medical Corp.2019-05-30
K170298Liberator Beacon Tip Locking StyletCook Incorporated2017-10-18
K142116LLD EZSpectranetics, Inc.2014-08-12
K090163STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078St Jude Medical2009-04-01
K080924MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151St. Jude Medical, Cardiac Rhythm Management Divisi2008-04-30
K072864ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEMSt. Jude Medical, Cardiac Rhythm Management Divisi2008-03-13
K053019ACUITY STEERABLE STYLET ACCESSORYGuidant Corporation2006-03-03
K052965EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.Guidant Corporation2006-02-13
K043401SPECTRANETICS LLD CS, MODEL 518-039Spectranetics Corp.2005-03-16
K040001STEERABLE STYLETSynovis Surgical Innovations2004-03-09
K010906MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254Medtronic Vascular2001-04-05
K003535STYLET KIT, MODELS 6254,6282,6293Medtronic Vascular2001-02-08
K002534EUPALAMUS DEFLECTABLE STYLET, MODEL 01545Eupalamus, LLC2000-10-18