DRB · Class II · 21 CFR 870.1380

FDA Product Code DRB: Stylet, Catheter

Leading manufacturers include Medtronic Vascular, Cardiac Pacemakers, Inc. and Spectranetics Corp..

28
Total
28
Cleared
115d
Avg days
1977
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Stylet, Catheter Devices (Product Code DRB)

28 devices
1–24 of 28
Cleared Aug 30, 2022
Arrow Stiffening Stylet
K220280
Arrow International, LLC (A subsidiary of Teleflex, Inc.)
Cardiovascular · 210d
Cleared Aug 01, 2019
Biotronik Stylets
K191469
Biotronik, Inc.
Cardiovascular · 59d
Cleared May 30, 2019
GaltTWS
K182660
Galt Medical Corp.
Cardiovascular · 247d
Cleared Oct 18, 2017
Liberator Beacon Tip Locking Stylet
K170298
Cook Incorporated
Cardiovascular · 260d
Cleared Aug 12, 2014
LLD EZ
K142116
Spectranetics, Inc.
Cardiovascular · 8d
Cleared Apr 01, 2009
STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078
K090163
St Jude Medical
Cardiovascular · 69d
Cleared Apr 30, 2008
MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151
K080924
St. Jude Medical, Cardiac Rhythm Management Divisi
Cardiovascular · 28d
Cleared Mar 13, 2008
ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM
K072864
St. Jude Medical, Cardiac Rhythm Management Divisi
Cardiovascular · 160d
Cleared Mar 03, 2006
ACUITY STEERABLE STYLET ACCESSORY
K053019
Guidant Corporation
Cardiovascular · 128d
Cleared Feb 13, 2006
EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.
K052965
Guidant Corporation
Cardiovascular · 115d
Cleared Mar 16, 2005
SPECTRANETICS LLD CS, MODEL 518-039
K043401
Spectranetics Corp.
Cardiovascular · 96d
Cleared Mar 09, 2004
STEERABLE STYLET
K040001
Synovis Surgical Innovations
Cardiovascular · 67d
Cleared Apr 05, 2001
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
K010906
Medtronic Vascular
Cardiovascular · 10d
Cleared Feb 08, 2001
STYLET KIT, MODELS 6254,6282,6293
K003535
Medtronic Vascular
Cardiovascular · 84d
Cleared Oct 18, 2000
EUPALAMUS DEFLECTABLE STYLET, MODEL 01545
K002534
Eupalamus, LLC
Cardiovascular · 63d
Cleared Jun 16, 2000
PLACER MODEL 6232 STEERABLE STYLET
K000955
Medtronic Vascular
Cardiovascular · 84d
Cleared Apr 14, 2000
FIXATION STYLETS, MODELS 335-287 AND 335-288
K000366
Accufix Research Institute
Cardiovascular · 70d
Cleared Apr 13, 2000
TFX MEDICAL STYLET CATHETER
K992664
Tfx Medical Group
Cardiovascular · 248d
Cleared Jan 05, 2000
ENSTYLET MODELS EC0010, EC0020
K993376
Endocardial Solutions, Inc.
Cardiovascular · 90d
Cleared Nov 12, 1999
LEAD STYLET,MODELS 6505,6506,6507,6508
K992863
Guidant Corp.
Cardiovascular · 79d
Cleared Oct 22, 1999
SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER
K990713
Spectranetics Corp.
Cardiovascular · 232d
Cleared Nov 22, 1991
TARGET THERAPEUTICS RADIOPAQUE STYLET
K914001
Target Therapeutics
Cardiovascular · 77d
Cleared Oct 04, 1991
THORACIC CATHETER STYLET
K913543
Intl. Medical Devices , Ltd.
Cardiovascular · 56d
Cleared Aug 28, 1991
THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER
K901281
Val-Mark Medical, Inc.
Cardiovascular · 527d

About Product Code DRB - Regulatory Context

510(k) Submission Activity

28 total 510(k) submissions under product code DRB since 1977, with 28 receiving FDA clearance (average review time: 115 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.