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 |
|---|---|---|---|
| 00840117309036 | Resp-O2 Single Suction Catheter, 16 Fr | Dynarex Corporation | 2022-05-10 |
| 00840117310322 | Resp-O2 Single Suction Catheter, 10 Fr | Dynarex Corporation | 2022-05-10 |
| 00840117310308 | Resp-O2 Single Suction Catheter, 8 Fr | Dynarex Corporation | 2022-05-10 |
| 00840117310285 | Resp-O2 Single Suction Catheter, 6 Fr | Dynarex Corporation | 2022-05-10 |
| 00840117309197 | Resp-O2 Suction Catheter Kit, 18 Fr | Dynarex Corporation | 2022-05-10 |
| 00840117309173 | Resp-O2 Suction Catheter Kit, 16 Fr | Dynarex Corporation | 2022-05-10 |
| 00840117309159 | Resp-O2 Suction Catheter Kit, 14 Fr | Dynarex Corporation | 2022-05-10 |
| 00840117309135 | Resp-O2 Suction Catheter Kit, 12 Fr | Dynarex Corporation | 2022-05-10 |
| 00840117309098 | Resp-O2 Suction Catheter Kit, 8 Fr | Dynarex Corporation | 2022-05-10 |
| 00840117309074 | Resp-O2 Suction Catheter Kit, 6 Fr | Dynarex Corporation | 2022-05-10 |
| 00840117309050 | Resp-O2 Single Suction Catheter, 18 Fr | Dynarex Corporation | 2022-05-10 |
| 00840117309012 | Resp-O2 Single Suction Catheter, 14 Fr | Dynarex Corporation | 2022-05-10 |
| 00840117308992 | Resp-O2 Single Suction Catheter, 12 Fr | Dynarex Corporation | 2022-05-10 |
| 00840117313453 | Resp-O2 Suction Catheter Kit, Mini-Tray, 8 Fr, Pediatric | Dynarex Corporation | 2022-04-21 |
| 00840117313477 | Resp-O2 Suction Catheter Mini-Kit, Adult, 10 Fr | Dynarex Corporation | 2022-04-21 |
| 00840117313491 | Resp-O2 Suction Catheter Mini-Kit, Adult, 12 Fr | Dynarex Corporation | 2022-04-21 |
| 00840117313514 | Resp-O2 Suction Catheter Mini-Kit, Adult, 14 Fr | Dynarex Corporation | 2022-04-21 |
| 00840117319486 | Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE) | Dynarex Corporation | 2021-04-22 |
| 00840117318144 | Resp-O2 Closed Suction Endotracheal Catheters, Sterile | Dynarex Corporation | 2021-04-22 |
| 00840117318168 | Resp-O2 Closed Suction Endotracheal Catheter Double Swivel Elbow (DSE) | Dynarex Corporation | 2021-04-22 |
| 00840117319462 | Resp-O2 Closed Suction Tracheal Catheter, T-Piece, Adult | Dynarex Corporation | 2021-04-22 |
| 00840117305670 | Resp-O2 Closed Suction Tracheal Catheters, T-Piece, Adult/Pediatric | Dynarex Corporation | 2021-04-22 |
| 00840117307339 | Resp-O2 Closed Suction Endotracheal Catheters, Double Swivel Elbow (DSE) | Dynarex Corporation | 2021-04-22 |
| 00840117305809 | Resp-O2 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE) | Dynarex Corporation | 2021-04-22 |
| 00840117305786 | Resp-O2 Closed Suction Endotracheal Catheter, T-Piece, Adult | Dynarex Corporation | 2021-04-22 |
| 00840117305779 | Resp-O2 Closed Suction Endotracheal Catheter, T-Piece, Adult/Pediatric | Dynarex Corporation | 2021-04-22 |
| 00840117305755 | Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE) | Dynarex Corporation | 2021-04-22 |
| 00840117305731 | Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE) | Dynarex Corporation | 2021-04-22 |
| 00840117305717 | Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE) | Dynarex Corporation | 2021-04-22 |
| 00840117305694 | Resp-O2 Closed Suction Tracheal Catheter, T-Piece, Adult | Dynarex Corporation | 2021-04-22 |