BSYClass I
Catheters, Suction, Tracheobronchial
21 CFR 868.6810 / Anesthesiology
BSY is the FDA product code for Catheters, Suction, Tracheobronchial, a class I device type, regulated under 21 CFR 868.6810. As of , FDA records hold 116 510(k) clearances under this code, the most recent dated , and 89 recalls.
Classification record
- Product code
- BSY
- Device name
- Catheters, Suction, Tracheobronchial
- Regulation
- 21 CFR 868.6810
- Device class
- Class I
- Review panel
- Anesthesiology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 116
- Ingested recalls
- 89
Clearances, product code BSY
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1979 | 2 |
| 1980 | 3 |
| 1981 | 7 |
| 1982 | 4 |
| 1983 | 2 |
| 1984 | 9 |
| 1985 | 9 |
| 1986 | 6 |
| 1987 | 13 |
| 1988 | 4 |
| 1989 | 10 |
| 1990 | 11 |
| 1991 | 6 |
| 1992 | 2 |
| 1993 | 4 |
| 1994 | 5 |
| 1995 | 6 |
| 1996 | 3 |
| 1997 | 4 |
| 1998 | 2 |
| 1999 | 1 |
| 2003 | 1 |
Applicants with the most clearances
Product code BSY| Applicant | Clearances |
|---|---|
| Sherwood Medical Co. | 7 |
| Ballard Medical Products | 5 |
| Ackrad Laboratories | 4 |
| American Pharmaseal Div. Ahsc | 4 |
| Concord Laboratories, Inc. | 3 |
| Concord/Portex | 3 |
| Puritas Health Care, Inc. | 3 |
| Busse Hospital Disposables | 2 |
| Contour Fabricators of Florida, Inc. | 2 |
| Medi-Craft, Ltd. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Abbott Medical
- AD Supply Group Limited
- Aero Healthcare
- Allied Medical LLC
- Amarigo Inc
- Amsino Medical (Kunshan) Co., Ltd.
- Amsino Medical (Shanghai) Co., Ltd.
- Amsino Medical Group (HK) Company Limited
- Angiplast Pvt. Ltd.
- Anji Hongde Medical Products Co., Ltd.
- Anji Spenq Industrial Co., Ltd.
- Aoj Health Technology Co., Ltd.
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.
