HCGClass II
Device, Neurovascular Embolization
21 CFR 882.5950 / Neurology
HCG is the FDA product code for Device, Neurovascular Embolization, a class II device type, regulated under 21 CFR 882.5950. As of , FDA records hold 187 510(k) clearances under this code, the most recent dated , and 68 recalls.
Classification record
- Product code
- HCG
- Device name
- Device, Neurovascular Embolization
- Regulation
- 21 CFR 882.5950
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 187
- Ingested recalls
- 68
Clearances, product code HCG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1987 | 1 |
| 1989 | 1 |
| 1990 | 2 |
| 1991 | 3 |
| 1992 | 1 |
| 1993 | 3 |
| 1994 | 2 |
| 1995 | 2 |
| 1996 | 4 |
| 1997 | 3 |
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 7 |
| 2001 | 4 |
| 2002 | 10 |
| 2003 | 14 |
| 2004 | 9 |
| 2005 | 8 |
| 2006 | 5 |
| 2007 | 8 |
| 2008 | 9 |
| 2009 | 7 |
| 2010 | 8 |
| 2011 | 9 |
| 2012 | 7 |
| 2013 | 7 |
| 2014 | 5 |
| 2015 | 5 |
| 2016 | 7 |
| 2017 | 5 |
| 2018 | 4 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 5 |
| 2022 | 3 |
| 2023 | 2 |
| 2024 | 4 |
| 2025 | 3 |
| 2026 | 4 |
Applicants with the most clearances
Product code HCG| Applicant | Clearances |
|---|---|
| Terumo Cardiovascular Systems Corporation | 32 |
| Boston Scientific Corporation | 22 |
| Cordis Neurovascular, Inc. | 13 |
| Medtronic, Inc. | 11 |
| Micrus Endovascular Corporation | 11 |
| Stryker Corp. | 11 |
| Penumbra Inc. | 10 |
| Cerenovus, Inc. | 9 |
| Target Therapeutics | 9 |
| Interventional Therapeutics Corp. | 7 |
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.