FDA Product Code
FDA Product Code DRB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1380
510(k) Clearances — 28 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K220280 | Arrow Stiffening Stylet | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2022-08-30 | Traditional | PDF ↗ |
| K191469 | Biotronik Stylets | Biotronik, Inc. | 2019-08-01 | Traditional | PDF ↗ |
| K182660 | GaltTWS | Galt Medical Corp. | 2019-05-30 | Traditional | PDF ↗ |
| K170298 | Liberator Beacon Tip Locking Stylet | Cook Incorporated | 2017-10-18 | Traditional | PDF ↗ |
| K142116 | LLD EZ | Spectranetics, Inc. | 2014-08-12 | Special | PDF ↗ |
| K090163 | STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 | St Jude Medical | 2009-04-01 | Traditional | PDF ↗ |
| K080924 | MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 | St. Jude Medical, Cardiac Rhythm Management Divisi | 2008-04-30 | Traditional | PDF ↗ |
| K072864 | ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM | St. Jude Medical, Cardiac Rhythm Management Divisi | 2008-03-13 | Traditional | PDF ↗ |
| K053019 | ACUITY STEERABLE STYLET ACCESSORY | Guidant Corporation | 2006-03-03 | Traditional | PDF ↗ |
| K052965 | EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. | Guidant Corporation | 2006-02-13 | Traditional | PDF ↗ |
| K043401 | SPECTRANETICS LLD CS, MODEL 518-039 | Spectranetics Corp. | 2005-03-16 | Traditional | PDF ↗ |
| K040001 | STEERABLE STYLET | Synovis Surgical Innovations | 2004-03-09 | Traditional | PDF ↗ |
| K010906 | MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254 | Medtronic Vascular | 2001-04-05 | Traditional | PDF ↗ |
| K003535 | STYLET KIT, MODELS 6254,6282,6293 | Medtronic Vascular | 2001-02-08 | Traditional | PDF ↗ |
| K002534 | EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 | Eupalamus, LLC | 2000-10-18 | Traditional | PDF ↗ |
| K000955 | PLACER MODEL 6232 STEERABLE STYLET | Medtronic Vascular | 2000-06-16 | Traditional | PDF ↗ |
| K000366 | FIXATION STYLETS, MODELS 335-287 AND 335-288 | Accufix Research Institute | 2000-04-14 | Traditional | PDF ↗ |
| K992664 | TFX MEDICAL STYLET CATHETER | Tfx Medical Group | 2000-04-13 | Traditional | PDF ↗ |
| K993376 | ENSTYLET MODELS EC0010, EC0020 | Endocardial Solutions, Inc. | 2000-01-05 | Traditional | PDF ↗ |
| K992863 | LEAD STYLET,MODELS 6505,6506,6507,6508 | Guidant Corp. | 1999-11-12 | Traditional | PDF ↗ |
| K990713 | SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER | Spectranetics Corp. | 1999-10-22 | Traditional | PDF ↗ |
| K914001 | TARGET THERAPEUTICS RADIOPAQUE STYLET | Target Therapeutics | 1991-11-22 | Traditional | PDF ↗ |
| K913543 | THORACIC CATHETER STYLET | Intl. Medical Devices , Ltd. | 1991-10-04 | Traditional | PDF ↗ |
| K901281 | THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER | Val-Mark Medical, Inc. | 1991-08-28 | Traditional | PDF ↗ |
| K905674 | LEAD STYLET | Cardiac Pacemakers, Inc. | 1991-01-30 | Traditional | PDF ↗ |
| K882097 | TUNNELING STYLET | Quinton, Inc. | 1988-07-28 | Traditional | PDF ↗ |
| K802076 | STIFF STYLETS | Cardiac Pacemakers, Inc. | 1980-09-26 | Traditional | PDF ↗ |
| K770404 | OBTURATOR | Abbott Laboratories | 1977-03-16 | Traditional | PDF ↗ |
Product code DRB · Class II · Cardiovascular. Data: openFDA.