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 |
| K952395 | REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION | Contour Fabricators of Florida, Inc. | 1995-08-15 |
| K952396 | REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION | 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#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840117352056 | Resp-O2 Single Suction Catheters, Adult Graduated Catheter, Control Valve | Dynarex Corporation | 2026-07-31 |
| 00840117352025 | Resp-O2 Single Suction Catheters, Adult Graduated Catheter, Control Valve | Dynarex Corporation | 2026-07-31 |
| 00840117351998 | Resp-O2 Single Suction Catheters, Adult Graduated Catheter, Control Valve | Dynarex Corporation | 2026-07-31 |
| 00840117351967 | Resp-O2 Single Suction Catheters, Adult Graduated Catheter, Control Valve | Dynarex Corporation | 2026-07-31 |
| 00840117351936 | Resp-O2 Single Suction Catheters, Adult Graduated Catheter, Control Valve | Dynarex Corporation | 2026-07-31 |
| 00840117351875 | Resp-O2 Single Suction Catheters, Pediatric Graduated Catheter | Dynarex Corporation | 2026-07-31 |
| 00840117351905 | Resp-O2 Single Suction Catheters, Pediatric Graduated Catheter, Control Valve | Dynarex Corporation | 2026-07-31 |
| 10889483564608 | BALLARD™ | SUNMED, LLC | 2025-11-24 |
| 10889483564646 | BALLARD™ | SUNMED, LLC | 2025-11-24 |
| 10889483567005 | BALLARD™ | SUNMED, LLC | 2025-11-24 |
| 10889483564486 | BALLARD™ | SUNMED, LLC | 2025-11-21 |
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| 10889483564691 | BALLARD™ | SUNMED, LLC | 2025-11-21 |
| 10889483564875 | BALLARD™ | SUNMED, LLC | 2025-11-21 |
| 10889483564882 | BALLARD™ | SUNMED, LLC | 2025-11-21 |
| 10889483564899 | BALLARD™ | SUNMED, LLC | 2025-11-21 |
| 10889483564370 | BALLARD™ | SUNMED, LLC | 2025-11-21 |
| 10889483562611 | BALLARD™ | SUNMED, LLC | 2025-11-21 |
| 10889483623541 | BALLARD™ | SUNMED, LLC | 2025-11-21 |
| 10889483564936 | BALLARD™ | SUNMED, LLC | 2025-11-21 |
| 10889483564905 | BALLARD™ | SUNMED, LLC | 2025-11-21 |
| 10889483564813 | BALLARD™ | SUNMED, LLC | 2025-11-21 |
| 10889483564806 | BALLARD™ | SUNMED, LLC | 2025-11-21 |
| 10889483564394 | BALLARD™ | SUNMED, LLC | 2025-11-21 |
| 10889483623411 | BALLARD™ | SUNMED, LLC | 2025-11-20 |
| 10889483564288 | BALLARD™ | SUNMED, LLC | 2025-11-20 |