Stylet, Catheter
FDA product code DRB · Class II (moderate risk) · 21 CFR 870.1380 · Cardiovascular
28510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Spectranetics Corp. 3
- Guidant Corp. 3
- Medtronic Vascular 3
- Cardiac Pacemakers, Inc. 2
- St. Jude Medical, Cardiac Rhythm Management Divisi 2
- Arrow International, LLC (A subsidiary of Teleflex, Inc.) 1
- Abbott Laboratories 1
- Biotronik, Inc. 1
- Galt Medical Corporation 1
- Cook, Inc. 1
- St Jude Medical 1
- Synovis Surgical Innovations 1
- Eupalamus, LLC 1
- Accufix Research Institute 1
- Tfx Medical Group 1
- Endocardial Solutions, Inc. 1
- Target Therapeutics 1
- Intl. Medical Devices , Ltd. 1
- Val-Mark Medical, Inc. 1
- Quinton, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220280 | Arrow Stiffening StyletDRB · Traditional | Arrow International, LLC (A subsidiary of… | 08/30/2022SE |
| K191469 | Biotronik StyletsDRB · Traditional | Biotronik, Inc. | 08/01/2019SE |
| K182660 | GaltTWSDRB · Traditional | Galt Medical Corp. | 05/30/2019SE |
| K170298 | Liberator Beacon Tip Locking StyletDRB · Traditional | Cook Incorporated | 10/18/2017SE |
| K142116 | LLD EzDRB · Special | Spectranetics, Inc. | 08/12/2014SE |
| K090163 | Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078DRB · Traditional | St Jude Medical | 04/01/2009SE |
| K080924 | Mond Rvot Stylet Models 4140, 4141, 4150, 4151DRB · Traditional | St. Jude Medical, Cardiac Rhythm Management Divisi | 04/30/2008SE |
| K072864 | St. Jude Medical, CPS Duo Left Heart Lead Delivery SystemDRB · Traditional | St. Jude Medical, Cardiac Rhythm Management Divisi | 03/13/2008SE |
| K053019 | Acuity Steerable Stylet AccessoryDRB · Traditional | Guidant Corporation | 03/03/2006SE |
| K052965 | Easytrak 2 Stylet, Models 4826, 4829, 4832.DRB · Traditional | Guidant Corporation | 02/13/2006SE |
| K043401 | Spectranetics LLD CS, Model 518-039DRB · Traditional | Spectranetics Corp. | 03/16/2005SE |
| K040001 | Steerable StyletDRB · Traditional | Synovis Surgical Innovations | 03/09/2004SE |
| K010906 | Medtronic Stylet Kit, Models 6282, 6293, and 6254DRB · Traditional | Medtronic Vascular | 04/05/2001SE |
| K003535 | Stylet Kit, Models 6254,6282,6293DRB · Traditional | Medtronic Vascular | 02/08/2001SE |
| K002534 | Eupalamus Deflectable Stylet, Model 01545DRB · Traditional | Eupalamus, LLC | 10/18/2000SE |
| K000955 | Placer Model 6232 Steerable StyletDRB · Traditional | Medtronic Vascular | 06/16/2000SE |
| K000366 | Fixation Stylets, Models 335-287 and 335-288DRB · Traditional | Accufix Research Institute | 04/14/2000SE |
| K992664 | TFX Medical Stylet CatheterDRB · Traditional | Tfx Medical Group | 04/13/2000SE |
| K993376 | Enstylet Models EC0010, EC0020DRB · Traditional | Endocardial Solutions, Inc. | 01/05/2000SE |
| K992863 | Lead Stylet,Models 6505,6506,6507,6508DRB · Traditional | Guidant Corp. | 11/12/1999SE |
| K990713 | Spectranetics Lead Locking Device (LLD) #1, #2, #3 ListerDRB · Traditional | Spectranetics Corp. | 10/22/1999SE |
| K914001 | Target Therapeutics Radiopaque StyletDRB · Traditional | Target Therapeutics | 11/22/1991SE |
| K913543 | Thoracic Catheter StyletDRB · Traditional | Intl. Medical Devices , Ltd. | 10/04/1991SE |
| K901281 | Thermo Kor-Continuous Pulmonary Artery ThermometerDRB · Traditional | Val-Mark Medical, Inc. | 08/28/1991SE |
| K905674 | Lead StyletDRB · Traditional | Cardiac Pacemakers, Inc. | 01/30/1991SE |
| K882097 | Tunneling StyletDRB · Traditional | Quinton, Inc. | 07/28/1988SE |
| K802076 | Stiff StyletsDRB · Traditional | Cardiac Pacemakers, Inc. | 09/26/1980SE |
| K770404 | ObturatorDRB · Traditional | Abbott Laboratories | 03/16/1977SE |