DQOClass II
Catheter, Intravascular, Diagnostic
21 CFR 870.1200 / Cardiovascular
DQO is the FDA product code for Catheter, Intravascular, Diagnostic, a class II device type, regulated under 21 CFR 870.1200. As of , FDA records hold 501 510(k) clearances under this code, the most recent dated , and 284 recalls.
Classification record
- Product code
- DQO
- Device name
- Catheter, Intravascular, Diagnostic
- Regulation
- 21 CFR 870.1200
- 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
- 501
- Ingested recalls
- 285
Clearances, product code DQO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 4 |
| 1977 | 5 |
| 1978 | 3 |
| 1979 | 4 |
| 1980 | 10 |
| 1981 | 7 |
| 1982 | 17 |
| 1983 | 21 |
| 1984 | 9 |
| 1985 | 11 |
| 1986 | 22 |
| 1987 | 9 |
| 1988 | 11 |
| 1989 | 13 |
| 1990 | 18 |
| 1991 | 36 |
| 1992 | 21 |
| 1993 | 23 |
| 1994 | 20 |
| 1995 | 13 |
| 1996 | 11 |
| 1997 | 16 |
| 1998 | 9 |
| 1999 | 9 |
| 2000 | 9 |
| 2001 | 11 |
| 2002 | 10 |
| 2003 | 9 |
| 2004 | 8 |
| 2005 | 8 |
| 2006 | 11 |
| 2007 | 8 |
| 2008 | 3 |
| 2009 | 8 |
| 2010 | 7 |
| 2011 | 6 |
| 2012 | 15 |
| 2013 | 2 |
| 2014 | 3 |
| 2015 | 10 |
| 2016 | 4 |
| 2017 | 10 |
| 2018 | 10 |
| 2019 | 6 |
| 2020 | 3 |
| 2021 | 1 |
| 2022 | 4 |
| 2023 | 4 |
| 2024 | 4 |
| 2025 | 2 |
| 2026 | 3 |
Applicants with the most clearances
Product code DQO| Applicant | Clearances |
|---|---|
| Boston Scientific Corporation | 41 |
| Cordis US Corp. | 30 |
| Abbott Medical | 16 |
| C.R. Bard Inc | 16 |
| Scimed Life Systems, Inc. | 16 |
| Vascular Solutions LLC | 12 |
| Cook Incorporated | 10 |
| Target Therapeutics | 10 |
| Mallinckrodt Critical Care | 9 |
| Cardiovascular Imaging Systems, Inc. | 8 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Abbott Medical
- Abbott Vascular
- Abbott Vascular Netherlands
- AD Supply Group Limited
- Advanced Lifesciences Pvt. Ltd.
- Advanced Vascular Dynamics
- Allwell Medical Corporation
- Amsino Medical (Kunshan) Co., Ltd.
- Antmed Malaysia Sdn Bhd
- Argon Medical Devices, Inc
- Arrotek Medical Ltd
- Arrow Internacional de Chihuahua S.A. de C.V.
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.
