FDA Product Code DRB: Stylet, Catheter
Leading manufacturers include Medtronic Vascular, Cardiac Pacemakers, Inc. and St Jude Medical.
28
Total
28
Cleared
115d
Avg days
1977
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Stylet, Catheter Devices (Product Code DRB)
28 devices
Cleared
Aug 30, 2022
Arrow Stiffening Stylet
Arrow International, LLC (A subsidiary of Teleflex, Inc.)
Cardiovascular
210d
Cleared
Aug 01, 2019
Biotronik Stylets
Biotronik, Inc.
Cardiovascular
59d
Cleared
May 30, 2019
GaltTWS
Galt Medical Corp.
Cardiovascular
247d
Cleared
Oct 18, 2017
Liberator Beacon Tip Locking Stylet
Cook Incorporated
Cardiovascular
260d
Cleared
Apr 01, 2009
STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078
St Jude Medical
Cardiovascular
69d
Cleared
Apr 05, 2001
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
Medtronic Vascular
Cardiovascular
10d
Cleared
Feb 08, 2001
STYLET KIT, MODELS 6254,6282,6293
Medtronic Vascular
Cardiovascular
84d
Cleared
Jun 16, 2000
PLACER MODEL 6232 STEERABLE STYLET
Medtronic Vascular
Cardiovascular
84d
Cleared
Nov 12, 1999
LEAD STYLET,MODELS 6505,6506,6507,6508
Guidant Corp.
Cardiovascular
79d
Cleared
Nov 22, 1991
TARGET THERAPEUTICS RADIOPAQUE STYLET
Target Therapeutics
Cardiovascular
77d
Cleared
Jan 30, 1991
LEAD STYLET
Cardiac Pacemakers, Inc.
Cardiovascular
43d
Cleared
Jul 28, 1988
TUNNELING STYLET
Quinton, Inc.
Cardiovascular
70d
Cleared
Sep 26, 1980
STIFF STYLETS
Cardiac Pacemakers, Inc.
Cardiovascular
29d
Cleared
Mar 16, 1977
OBTURATOR
Abbott Laboratories
Cardiovascular
13d
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 declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.