FDA 510(k) Applications for Medical Device Product Code "DRB"
(Stylet, Catheter)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K000366 |
ACCUFIX RESEARCH INSTITUTE |
FIXATION STYLETS, MODELS 335-287 AND 335-288 |
04/14/2000 |
K220280 |
Arrow International, LLC (a subsidiary of Teleflex, Inc.) |
Arrow Stiffening Stylet |
08/30/2022 |
K191469 |
Biotronik, Inc |
Biotronik Stylets |
08/01/2019 |
K170298 |
Cook Incorporated |
Liberator Beacon Tip Locking Stylet |
10/18/2017 |
K993376 |
ENDOCARDIAL SOLUTIONS, INC. |
ENSTYLET MODELS EC0010, EC0020 |
01/05/2000 |
K002534 |
EUPALAMUS, LLC. |
EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 |
10/18/2000 |
K182660 |
Galt Medical Corp. |
GaltTWS |
05/30/2019 |
K992863 |
GUIDANT CORP. |
LEAD STYLET,MODELS 6505,6506,6507,6508 |
11/12/1999 |
K053019 |
GUIDANT CORPORATION |
ACUITY STEERABLE STYLET ACCESSORY |
03/03/2006 |
K052965 |
GUIDANT CORPORATION |
EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. |
02/13/2006 |
K010906 |
MEDTRONIC VASCULAR |
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254 |
04/05/2001 |
K000955 |
MEDTRONIC VASCULAR |
PLACER MODEL 6232 STEERABLE STYLET |
06/16/2000 |
K003535 |
MEDTRONIC VASCULAR |
STYLET KIT, MODELS 6254,6282,6293 |
02/08/2001 |
K990713 |
SPECTRANETICS CORP. |
SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER |
10/22/1999 |
K043401 |
SPECTRANETICS CORP. |
SPECTRANETICS LLD CS, MODEL 518-039 |
03/16/2005 |
K142116 |
SPECTRANETICS, INC. |
LLD EZ |
08/12/2014 |
K090163 |
ST. JUDE MEDICAL |
STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 |
04/01/2009 |
K080924 |
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 |
04/30/2008 |
K072864 |
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM |
03/13/2008 |
K040001 |
SYNOVIS SURGICAL INNOVATIONS |
STEERABLE STYLET |
03/09/2004 |
K992664 |
TFX MEDICAL GROUP |
TFX MEDICAL STYLET CATHETER |
04/13/2000 |
|
|