DRB — Stylet, Catheter Class II
FDA product code DRB covers "Stylet, Catheter", a Class II medical device regulated under 21 CFR 870.1380. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DRB
- Device Class
- Class II
- Regulation Number
- 870.1380
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K220280 | arrow international, llc (a subsidiary of teleflex, inc.) | Arrow Stiffening Stylet | August 30, 2022 |
| K191469 | biotronik | Biotronik Stylets | August 1, 2019 |
| K182660 | galt medical | GaltTWS | May 30, 2019 |
| K170298 | cook incorporated | Liberator Beacon Tip Locking Stylet | October 18, 2017 |
| K142116 | spectranetics | LLD EZ | August 12, 2014 |
| K090163 | st jude medical | STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 | April 1, 2009 |
| K080924 | st. jude medical, cardiac rhythm management divisi | MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 | April 30, 2008 |
| K072864 | st. jude medical, cardiac rhythm management divisi | ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM | March 13, 2008 |
| K053019 | guidant corporation | ACUITY STEERABLE STYLET ACCESSORY | March 3, 2006 |
| K052965 | guidant corporation | EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. | February 13, 2006 |
| K043401 | spectranetics | SPECTRANETICS LLD CS, MODEL 518-039 | March 16, 2005 |
| K040001 | synovis surgical innovations | STEERABLE STYLET | March 9, 2004 |
| K010906 | medtronic vascular | MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254 | April 5, 2001 |
| K003535 | medtronic vascular | STYLET KIT, MODELS 6254,6282,6293 | February 8, 2001 |
| K002534 | eupalamus | EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 | October 18, 2000 |
| K000955 | medtronic vascular | PLACER MODEL 6232 STEERABLE STYLET | June 16, 2000 |
| K000366 | accufix research institute | FIXATION STYLETS, MODELS 335-287 AND 335-288 | April 14, 2000 |
| K992664 | tfx medical group | TFX MEDICAL STYLET CATHETER | April 13, 2000 |
| K993376 | endocardial solutions | ENSTYLET MODELS EC0010, EC0020 | January 5, 2000 |
| K992863 | guidant | LEAD STYLET,MODELS 6505,6506,6507,6508 | November 12, 1999 |