Product code BSY
- Device name
- Catheters, Suction, Tracheobronchial
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.6810
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K031997 | MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM | Mallinckrodt Dar S.R.L. | 2003-11-25 |
| K992902 | AMBU HAND POWER SUCTION PUMP | Ambu, Inc. | 1999-10-25 |
| K982945 | DUAL PURPOSE CLOSED CATHETER | Spirit Medical Systems, Inc. | 1998-09-22 |
| K981910 | SUCTION CATHETER | Ni-Med, Inc. | 1998-08-24 |
| K972258 | HI-CARE CLOSED SUCTION SYSTEM | Mallinckrodt Medical | 1997-12-29 |
| K973199 | AMSINO SUCTION CATHETER | Amsino Intl., Inc. | 1997-09-10 |
| K961707 | TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM | Sorenson Critical Care | 1997-03-11 |
| K964369 | TRACH CARE SET WITH MICROBAN | Ballard Medical Products | 1997-02-11 |
| K960488 | NEO 2 LINE SUCTION SYSTEM | Alcove Medical, Inc. | 1996-04-26 |
| K955831 | ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM | Sherwood Medical Co. | 1996-03-28 |
| K955645 | CATH-GUIDE | Hudson Respiratory Care, Inc. | 1996-03-12 |
| K952396 | REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION | Contour Fabricators of Florida, Inc. | 1995-08-15 |
| K952395 | REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION | Contour Fabricators of Florida, Inc. | 1995-08-15 |
| K953226 | PULM O2 SUCTION CATHETER TRAYS | Premium Plastics, Inc. | 1995-08-08 |
| K951506 | SUCTION CATHETER KIT, STERILE, SINGLE-USE | Trinity Laboratories, Inc. | 1995-07-03 |
| K945994 | DUAL PURPOSE CATHETER | Universal Medical Products, Inc. | 1995-06-21 |
| K951745 | CONNECTING TUBE | Vital Signs, Inc. | 1995-05-30 |
| K945950 | TRIGUARD(TM) SUCTION SYSTEM | Vital Signs, Inc. | 1994-12-27 |
| K944251 | KENDALL MODU-VAC CLOSED SUCTION SYSTEM | Kendall Healthcare Products Co. Div.Of Tyco Health | 1994-09-21 |
| K935600 | TRACHEAL SUCTION CATHETER | Puritas Health Care, Inc. | 1994-05-10 |
| K935583 | SUCTION SET, TRACHAEL | Puritas Health Care, Inc. | 1994-04-11 |
| K935553 | MULLY SUCTION STRAIGHT WITH FINGERTIP/WITH FUNNEL/WITH VACUTIP | Puritas Health Care, Inc. | 1994-01-14 |
| K934723 | ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM | Sherwood Medical Co. | 1993-11-30 |
| K925556 | ARGYLE ASPIR-FLEX SUCTION CATHETER | Sherwood Medical Co. | 1993-07-30 |
| K921851 | 4 SURE TM SUCTION CATHETERS & KITS | Boston Pacific Medical, Inc. | 1993-07-07 |
| K922843 | DYNAREX SUCTION CATHETERS & KITS | Dynarex Corp. | 1993-01-11 |
| K922148 | ARGYLE AERO-JET SUCTION CATHETER | Sherwood Medical Co. | 1992-12-07 |
| K923098 | STERILE MUCOUS SPECIMEN TRAP, DISPOSABLE | Trinity Laboratories, Inc. | 1992-09-21 |
| K903480 | HANN-VAC TM, DISPOSABLE,SUCTION CATHETER | Un-I-Med, Inc. | 1991-10-01 |
| K912596 | MECONIUM ASPIRATION | Pacific Device, Inc. | 1991-07-30 |
Related GUDID Devices#
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| 10080196033553 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-05-15 |
| 10080196033362 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-06-12 |
| 10080196033348 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-06-12 |
| 10080196033331 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-06-12 |
| 10080196033355 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-05-29 |
| 00072239325087 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239325070 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 10190752140639 | AirLife™ | AIRLIFE | 2022-09-05 |
| 10190752140653 | AirLife™ | AIRLIFE | 2022-09-05 |
| 10190752140660 | AirLife™ | AIRLIFE | 2022-09-05 |
| 10190752140684 | AirLife™ | AIRLIFE | 2022-09-05 |
| 10190752140691 | AirLife™ | AIRLIFE | 2022-09-05 |
| 10190752140707 | AirLife™ Closed Suction Catheter–Neonatal 8 Fr | AIRLIFE | 2022-09-05 |
| 10190752140622 | AirLife™ | AIRLIFE | 2022-09-05 |
| 10190752140615 | AirLife™ Closed Suction Catheter 14 Fr | AIRLIFE | 2022-09-05 |
| 10190752140578 | AirLife™ Closed Suction Catheter 10 Fr | AIRLIFE | 2022-09-05 |
| 10190752140608 | AirLife™ | AIRLIFE | 2022-09-05 |
| 10190752140585 | AirLife™ | AIRLIFE | 2022-09-05 |
| 10080196033300 | Medline | MEDLINE INDUSTRIES, INC. | 2021-10-20 |
| 10080196033294 | Medline | MEDLINE INDUSTRIES, INC. | 2021-10-20 |
| 08033055146333 | FLEXFORM LINE | H.S. HOSPITAL SERVICE SPA | 2021-03-01 |
| 08033003349410 | FLEXFORM LINE | H.S. HOSPITAL SERVICE SPA | 2021-03-01 |
| 08033003349403 | FLEXFORM LINE | H.S. HOSPITAL SERVICE SPA | 2021-03-01 |
| 08033003349397 | FLEXFORM LINE | H.S. HOSPITAL SERVICE SPA | 2021-03-01 |
| 10080196846771 | Medline | MEDLINE INDUSTRIES, INC. | 2020-12-30 |
| 10080196356621 | Medline | MEDLINE INDUSTRIES, INC. | 2020-10-30 |
| 10190752145474 | AirLife™ | AIRLIFE | 2020-02-03 |
| 10190752145481 | AirLife™ | AIRLIFE | 2020-02-03 |
| 10190752145498 | AirLife™ | AIRLIFE | 2020-02-03 |
| 10190752144477 | TRI-FLO™ | VYAIRE MEDICAL, INC. | 2019-12-20 |