FDA product code DRB: Stylet, Catheter
DRB is the FDA product code for stylet, catheter. It is a Class II device, regulated under 21 CFR 870.1380 and reviewed by the Cardiovascular panel. FDA has cleared 28 510(k) submissions under DRB, 1 in the last five years, from 22 different applicants. The average 510(k) review took 115 days (median 78).
Classification
| Field | Value |
|---|---|
| Device name | Stylet, Catheter |
| Device class | Class II |
| Regulation | 21 CFR 870.1380 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DRB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 260 |
| 2019 | 2 | 153 |
| 2022 | 1 | 210 |
Compare with all 510(k) review times · Search every DRB clearance
Top DRB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Vascular | 3 | 2001-04-05 |
| St. Jude Medical, Cardiac Rhythm Management Divisi | 2 | 2008-04-30 |
| Guidant Corporation | 2 | 2006-03-03 |
| Spectranetics Corp. | 2 | 2005-03-16 |
| Cardiac Pacemakers, Inc. | 2 | 1991-01-30 |
17 more applicants have DRB clearances. See the full list in Caduvo.
Most recent DRB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220280 | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | Arrow Stiffening Stylet | 2022-08-30 | 210 |
| K191469 | Biotronik, Inc. | Biotronik Stylets | 2019-08-01 | 59 |
| K182660 | Galt Medical Corp. | GaltTWS | 2019-05-30 | 247 |
| K170298 | Cook Incorporated | Liberator Beacon Tip Locking Stylet | 2017-10-18 | 260 |
| K142116 | Spectranetics, Inc. | LLD EZ | 2014-08-12 | 8 |
Recalls for DRB devices
openFDA lists no recalls for product code DRB.
Frequently asked questions
What is FDA product code DRB?
DRB is the FDA product code for stylet, catheter. It is a Class II device, regulated under 21 CFR 870.1380 and reviewed by the Cardiovascular panel.
What device class is DRB?
Class II, regulation 21 CFR 870.1380. Typical premarket route: 510(k).
How long does a 510(k) take for product code DRB?
Across 28 cleared submissions the average was 115 days from receipt to decision (median 78).
Which companies have the most DRB clearances?
Medtronic Vascular (3); St. Jude Medical, Cardiac Rhythm Management Divisi (2); Guidant Corporation (2); Spectranetics Corp. (2); Cardiac Pacemakers, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code DRB
- Run a recall and safety report across every DRB manufacturer
- Watch product code DRB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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