FDA product code DWB: Pump, Blood, Cardiopulmonary Bypass, Roller Type
DWB is the FDA product code for pump, blood, cardiopulmonary bypass, roller type. It is a Class II device, regulated under 21 CFR 870.4370 and reviewed by the Cardiovascular panel. FDA has cleared 21 510(k) submissions under DWB, from 14 different applicants. The average 510(k) review took 136 days (median 110). FDA has posted 2 recalls for DWB devices.
Classification
| Field | Value |
|---|---|
| Device name | Pump, Blood, Cardiopulmonary Bypass, Roller Type |
| Device class | Class II |
| Regulation | 21 CFR 870.4370 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every DWB clearance
Top DWB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stoeckert Instrumente | 3 | 1998-02-27 |
| 3M Health Care, Sarns | 3 | 1996-04-19 |
| Shiley, Inc. | 3 | 1989-04-12 |
| Terumo Cardiovascular Systems Corporation | 2 | 2016-11-17 |
| Terumo Cardiovascular Systems Corp. | 1 | 2011-12-19 |
9 more applicants have DWB clearances. See the full list in Caduvo.
Most recent DWB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K162843 | Terumo Cardiovascular Systems Corporation | Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 | 2016-11-17 | 37 |
| K131618 | Terumo Cardiovascular Systems Corporation | LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST | 2013-09-27 | 116 |
| K112587 | Terumo Cardiovascular Systems Corp. | ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR, | 2011-12-19 | 104 |
| K973237 | Medtronic Bio-Medicus, Inc. | CSS-CARDIOPLEGIA SAFETY SYSTEM | 1998-04-27 | 242 |
| K972321 | Stoeckert Instrumente | S3 MAST PUMP | 1998-02-27 | 249 |
Recalls for DWB devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-10-21.
Frequently asked questions
What is FDA product code DWB?
DWB is the FDA product code for pump, blood, cardiopulmonary bypass, roller type. It is a Class II device, regulated under 21 CFR 870.4370 and reviewed by the Cardiovascular panel.
What device class is DWB?
Class II, regulation 21 CFR 870.4370. Typical premarket route: 510(k).
How long does a 510(k) take for product code DWB?
Across 21 cleared submissions the average was 136 days from receipt to decision (median 110).
Which companies have the most DWB clearances?
Stoeckert Instrumente (3); 3M Health Care, Sarns (3); Shiley, Inc. (3); Terumo Cardiovascular Systems Corporation (2); Terumo Cardiovascular Systems Corp. (1).
Have DWB devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2011-10-21.
Next steps
- Run an FDA pathway report with predicate devices for product code DWB
- Run a recall and safety report across every DWB manufacturer
- Watch product code DWB 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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