Panels › Cardiovascular › Product code DRB · Class 2
Stylet, Catheter
Regulation 870.1380
0510(k)s in 12 months (28 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DRB
| Company | 510(k)s | Recalls |
|---|---|---|
| Guidant Corp. | 3 | 0 |
| Medtronic Vascular | 3 | 0 |
| Spectranetics Corp. | 3 | 0 |
| Cardiac Pacemakers, Inc. | 2 | 0 |
| St. Jude Medical, Cardiac Rhythm Management Divisi | 2 | 0 |
| Abbott Laboratories | 1 | 0 |
| Accufix Research Institute | 1 | 0 |
| Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 1 | 0 |
| Biotronik, Inc. | 1 | 0 |
| Cook Incorporated | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 30, 2022 | K220280 | Arrow Stiffening Stylet Arrow International, LLC (A subsidiary of Teleflex, Inc.) | DRB |
| Aug 1, 2019 | K191469 | Biotronik Stylets Biotronik, Inc. | DRB |
| May 30, 2019 | K182660 | GaltTWS Galt Medical Corp. | DRB |
| Oct 18, 2017 | K170298 | Liberator Beacon Tip Locking Stylet Cook Incorporated | DRB |
| Aug 12, 2014 | K142116 | LLD EZ Spectranetics, Inc. | DRB |
| Apr 1, 2009 | K090163 | STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 St Jude Medical | DRB |
| Apr 30, 2008 | K080924 | MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 St. Jude Medical, Cardiac Rhythm Management Divisi | DRB |
| Mar 13, 2008 | K072864 | ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM St. Jude Medical, Cardiac Rhythm Management Divisi | DRB |
| Mar 3, 2006 | K053019 | ACUITY STEERABLE STYLET ACCESSORY Guidant Corporation | DRB |
| Feb 13, 2006 | K052965 | EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. Guidant Corporation | DRB |
| Mar 16, 2005 | K043401 | SPECTRANETICS LLD CS, MODEL 518-039 Spectranetics Corp. | DRB |
| Mar 9, 2004 | K040001 | STEERABLE STYLET Synovis Surgical Innovations | DRB |
| Apr 5, 2001 | K010906 | MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254 Medtronic Vascular | DRB |
| Feb 8, 2001 | K003535 | STYLET KIT, MODELS 6254,6282,6293 Medtronic Vascular | DRB |
| Oct 18, 2000 | K002534 | EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 Eupalamus, LLC | DRB |
| Jun 16, 2000 | K000955 | PLACER MODEL 6232 STEERABLE STYLET Medtronic Vascular | DRB |
| Apr 14, 2000 | K000366 | FIXATION STYLETS, MODELS 335-287 AND 335-288 Accufix Research Institute | DRB |
| Apr 13, 2000 | K992664 | TFX MEDICAL STYLET CATHETER Tfx Medical Group | DRB |
| Jan 5, 2000 | K993376 | ENSTYLET MODELS EC0010, EC0020 Endocardial Solutions, Inc. | DRB |
| Nov 12, 1999 | K992863 | LEAD STYLET,MODELS 6505,6506,6507,6508 Guidant Corp. | DRB |
| Oct 22, 1999 | K990713 | SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER Spectranetics Corp. | DRB |
| Nov 22, 1991 | K914001 | TARGET THERAPEUTICS RADIOPAQUE STYLET Target Therapeutics | DRB |
| Oct 4, 1991 | K913543 | THORACIC CATHETER STYLET Intl. Medical Devices , Ltd. | DRB |
| Aug 28, 1991 | K901281 | THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER Val-Mark Medical, Inc. | DRB |
| Jan 30, 1991 | K905674 | LEAD STYLET Cardiac Pacemakers, Inc. | DRB |
| Jul 28, 1988 | K882097 | TUNNELING STYLET Quinton, Inc. | DRB |
| Sep 26, 1980 | K802076 | STIFF STYLETS Cardiac Pacemakers, Inc. | DRB |
| Mar 16, 1977 | K770404 | OBTURATOR Abbott Laboratories | DRB |
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