FDA product code DTP: Defoamer, Cardiopulmonary Bypass
DTP is the FDA product code for defoamer, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4230 and reviewed by the Cardiovascular panel. FDA has cleared 34 510(k) submissions under DTP, from 18 different applicants. The average 510(k) review took 81 days (median 82).
Classification
| Field | Value |
|---|---|
| Device name | Defoamer, Cardiopulmonary Bypass |
| Device class | Class II |
| Regulation | 21 CFR 870.4230 |
| 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 DTP clearance
Top DTP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Vascular | 4 | 1993-10-15 |
| Scimed Life Systems, Inc. | 4 | 1986-02-26 |
| Shiley, Inc. | 4 | 1985-11-14 |
| C.R. Bard, Inc. | 3 | 1999-03-09 |
| Gish Biomedical, Inc. | 3 | 1988-01-19 |
13 more applicants have DTP clearances. See the full list in Caduvo.
Most recent DTP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K101186 | Medtronic Perfusion Systems | AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG | 2010-09-03 | 128 |
| K082412 | Mapquet Cardiopulmonary AG | VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160 | 2008-11-10 | 81 |
| K004046 | Cobe Cardiovascular, Inc. | COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR | 2001-04-26 | 118 |
| K002591 | Cobe Cardiovascular, Inc. | COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR | 2000-09-13 | 23 |
| K990514 | C.R. Bard, Inc. | MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR | 1999-03-09 | 19 |
Recalls for DTP devices
openFDA lists no recalls for product code DTP.
Frequently asked questions
What is FDA product code DTP?
DTP is the FDA product code for defoamer, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4230 and reviewed by the Cardiovascular panel.
What device class is DTP?
Class II, regulation 21 CFR 870.4230. Typical premarket route: 510(k).
How long does a 510(k) take for product code DTP?
Across 34 cleared submissions the average was 81 days from receipt to decision (median 82).
Which companies have the most DTP clearances?
Medtronic Vascular (4); Scimed Life Systems, Inc. (4); Shiley, Inc. (4); C.R. Bard, Inc. (3); Gish Biomedical, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code DTP
- Run a recall and safety report across every DTP manufacturer
- Watch product code DTP 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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