Atlas FDA

DRB

28 FDA 510(k) clearances · Product code

79 daysmedian time to decision
248 days90th percentile
28clearances measured

FDA profile

Official device name
Stylet, Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1380
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 97 · 2022: 94 · 2023: 82 · 2024: 116 · 2025: 154 · 2026: 79
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Arrow Stiffening Stylet (K220280)Arrow International, LLC (A subsidiary of Teleflex, Inc.)2022-08-30
Biotronik Stylets (K191469)Biotronik, Inc.2019-08-01
GaltTWS (K182660)Galt Medical Corp.2019-05-30
Liberator Beacon Tip Locking Stylet (K170298)Cook Incorporated2017-10-18
LLD EZ (K142116)Spectranetics, Inc.2014-08-12
STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 (K090163)St Jude Medical2009-04-01
MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 (K080924)St. Jude Medical, Cardiac Rhythm Management Divisi2008-04-30
ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM (K072864)St. Jude Medical, Cardiac Rhythm Management Divisi2008-03-13
ACUITY STEERABLE STYLET ACCESSORY (K053019)Guidant Corporation2006-03-03
EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. (K052965)Guidant Corporation2006-02-13
SPECTRANETICS LLD CS, MODEL 518-039 (K043401)Spectranetics Corp.2005-03-16
STEERABLE STYLET (K040001)Synovis Surgical Innovations2004-03-09
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254 (K010906)Medtronic Vascular2001-04-05
STYLET KIT, MODELS 6254,6282,6293 (K003535)Medtronic Vascular2001-02-08
EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 (K002534)Eupalamus, LLC2000-10-18
PLACER MODEL 6232 STEERABLE STYLET (K000955)Medtronic Vascular2000-06-16
FIXATION STYLETS, MODELS 335-287 AND 335-288 (K000366)Accufix Research Institute2000-04-14
TFX MEDICAL STYLET CATHETER (K992664)Tfx Medical Group2000-04-13
ENSTYLET MODELS EC0010, EC0020 (K993376)Endocardial Solutions, Inc.2000-01-05
LEAD STYLET,MODELS 6505,6506,6507,6508 (K992863)Guidant Corp.1999-11-12
SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER (K990713)Spectranetics Corp.1999-10-22
TARGET THERAPEUTICS RADIOPAQUE STYLET (K914001)Target Therapeutics1991-11-22
THORACIC CATHETER STYLET (K913543)Intl. Medical Devices , Ltd.1991-10-04
THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER (K901281)Val-Mark Medical, Inc.1991-08-28
LEAD STYLET (K905674)Cardiac Pacemakers, Inc.1991-01-30
TUNNELING STYLET (K882097)Quinton, Inc.1988-07-28
STIFF STYLETS (K802076)Cardiac Pacemakers, Inc.1980-09-26
OBTURATOR (K770404)Abbott Laboratories1977-03-16

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Every clearance here is in the API, with alerts when new ones post.