DTRClass II
Heat-Exchanger, Cardiopulmonary Bypass
21 CFR 870.4240 / Cardiovascular
DTR is the FDA product code for Heat-Exchanger, Cardiopulmonary Bypass, a class II device type, regulated under 21 CFR 870.4240. As of , FDA records hold 91 510(k) clearances under this code, the most recent dated , and 33 recalls.
Classification record
- Product code
- DTR
- Device name
- Heat-Exchanger, Cardiopulmonary Bypass
- Regulation
- 21 CFR 870.4240
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- Yes
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 91
- Ingested recalls
- 35
Clearances, product code DTR
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 3 |
| 1978 | 3 |
| 1979 | 2 |
| 1980 | 4 |
| 1981 | 3 |
| 1982 | 2 |
| 1983 | 4 |
| 1984 | 4 |
| 1985 | 5 |
| 1986 | 3 |
| 1987 | 3 |
| 1988 | 7 |
| 1989 | 1 |
| 1990 | 5 |
| 1991 | 5 |
| 1992 | 2 |
| 1993 | 4 |
| 1995 | 2 |
| 1996 | 1 |
| 1997 | 3 |
| 1999 | 1 |
| 2000 | 2 |
| 2001 | 2 |
| 2002 | 2 |
| 2003 | 1 |
| 2004 | 2 |
| 2008 | 1 |
| 2009 | 2 |
| 2017 | 2 |
| 2018 | 1 |
| 2020 | 2 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 1 |
Applicants with the most clearances
Product code DTR| Applicant | Clearances |
|---|---|
| Shiley, Inc. | 11 |
| Gish Biomedical, Inc. | 10 |
| Medtronic, Inc. | 7 |
| 3M Health Care, Sarns | 6 |
| Quest Medical, Inc | 5 |
| American Bentley | 4 |
| Spectrum Medical Inc | 4 |
| LivaNova USA, Inc. | 3 |
| Cobe Laboratories, Inc. | 3 |
| Electro-Catheter Corp. | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.