DRB · Stylet, Catheter
Cardiovascular · 21 CFR 870.1380 · Class 2
Overview
| Product Code | DRB |
|---|---|
| Device Name | Stylet, Catheter |
| Regulation | 21 CFR 870.1380 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 28)
Showing 20 most recent of 28 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K220280 | Arrow Stiffening Stylet | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | Aug 30, 2022 | SESE |
| K191469 | Biotronik Stylets | Biotronik, Inc. | Aug 1, 2019 | SESE |
| K182660 | GaltTWS | Galt Medical Corp. | May 30, 2019 | SESE |
| K170298 | Liberator Beacon Tip Locking Stylet | Cook Incorporated | Oct 18, 2017 | SESE |
| K142116 | LLD EZ | Spectranetics, Inc. | Aug 12, 2014 | SESE |
| K090163 | STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 | St Jude Medical | Apr 1, 2009 | SESE |
| K080924 | MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 | St. Jude Medical, Cardiac Rhythm Management Divisi | Apr 30, 2008 | SESE |
| K072864 | ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM | St. Jude Medical, Cardiac Rhythm Management Divisi | Mar 13, 2008 | SESE |
| K053019 | ACUITY STEERABLE STYLET ACCESSORY | Guidant Corporation | Mar 3, 2006 | SESE |
| K052965 | EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. | Guidant Corporation | Feb 13, 2006 | SESE |
| K043401 | SPECTRANETICS LLD CS, MODEL 518-039 | Spectranetics Corp. | Mar 16, 2005 | SESE |
| K040001 | STEERABLE STYLET | Synovis Surgical Innovations | Mar 9, 2004 | SESE |
| K010906 | MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254 | Medtronic Vascular | Apr 5, 2001 | SESE |
| K003535 | STYLET KIT, MODELS 6254,6282,6293 | Medtronic Vascular | Feb 8, 2001 | SESE |
| K002534 | EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 | Eupalamus, LLC | Oct 18, 2000 | SESE |
| K000955 | PLACER MODEL 6232 STEERABLE STYLET | Medtronic Vascular | Jun 16, 2000 | SESE |
| K000366 | FIXATION STYLETS, MODELS 335-287 AND 335-288 | Accufix Research Institute | Apr 14, 2000 | SESE |
| K992664 | TFX MEDICAL STYLET CATHETER | Tfx Medical Group | Apr 13, 2000 | SESE |
| K993376 | ENSTYLET MODELS EC0010, EC0020 | Endocardial Solutions, Inc. | Jan 5, 2000 | SESE |
| K992863 | LEAD STYLET,MODELS 6505,6506,6507,6508 | Guidant Corp. | Nov 12, 1999 | SESE |
Top Applicants
- Medtronic Vascular — 3 clearances
- Cardiac Pacemakers, Inc. — 2 clearances
- Guidant Corporation — 2 clearances
- Spectranetics Corp. — 2 clearances
- St. Jude Medical, Cardiac Rhythm Management Divisi — 2 clearances
