DRBClass II
Stylet, Catheter
21 CFR 870.1380 / Cardiovascular
DRB is the FDA product code for Stylet, Catheter, a class II device type, regulated under 21 CFR 870.1380. As of , FDA records hold 28 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- DRB
- Device name
- Stylet, Catheter
- Regulation
- 21 CFR 870.1380
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 28
- Ingested recalls
- 0
Clearances, product code DRB
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1980 | 1 |
| 1988 | 1 |
| 1991 | 4 |
| 1999 | 2 |
| 2000 | 5 |
| 2001 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 2 |
| 2008 | 2 |
| 2009 | 1 |
| 2014 | 1 |
| 2017 | 1 |
| 2019 | 2 |
| 2022 | 1 |
Applicants with the most clearances
Product code DRB| Applicant | Clearances |
|---|---|
| Boston Scientific Corporation | 3 |
| Medtronic, Inc. | 3 |
| Spectranetics Corp. | 3 |
| Abbott Medical | 2 |
| Cardiac Pacemakers, Inc. | 2 |
| St. Jude Medical, Cardiac Rhythm Management Divisi | 2 |
| Accufix Research Institute | 1 |
| Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 1 |
| BIOTRONIK AG | 1 |
| Cook Incorporated | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Abbott Medical
- Acme-Monaco Corp.
- Addn Solutions GmbH & Co. KG
- Arrow Internacional de Chihuahua S.A. de C.V.
- Arrow International LLC (subsidiary of Teleflex Incorporated)
- AvailMed S.A.De C.V.
- BIOTRONIK AG
- BIOTRONIK SE & Co. KG
- Boston Scientific Corporation
- Cardinal Health Costa Rica, S.A.
- Cook Incorporated
- Cook Vandergrift, Inc.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.