DRB · Class II · 21 CFR 870.1380

FDA Product Code DRB: Stylet, Catheter

Leading manufacturers include Medtronic Vascular, Cook Incorporated and Galt Medical Corp..

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
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 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 Jun 16, 2000
PLACER MODEL 6232 STEERABLE STYLET
K000955
Medtronic Vascular
Cardiovascular · 84d
Cleared Mar 16, 1977
OBTURATOR
K770404
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.