BSY · Catheters, Suction, Tracheobronchial
Anesthesiology · 21 CFR 868.6810 · Class 1
Overview
| Product Code | BSY |
|---|---|
| Device Name | Catheters, Suction, Tracheobronchial |
| Regulation | 21 CFR 868.6810 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.
Classification Rationale
Class 1 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.
Recent Cleared Devices (20 of 116)
Showing 20 most recent of 116 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K031997 | MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM | Mallinckrodt Dar S.R.L. | Nov 25, 2003 | SESE |
| K992902 | AMBU HAND POWER SUCTION PUMP | Ambu, Inc. | Oct 25, 1999 | SESE |
| K982945 | DUAL PURPOSE CLOSED CATHETER | Spirit Medical Systems, Inc. | Sep 22, 1998 | SESE |
| K981910 | SUCTION CATHETER | Ni-Med, Inc. | Aug 24, 1998 | SESE |
| K972258 | HI-CARE CLOSED SUCTION SYSTEM | Mallinckrodt Medical | Dec 29, 1997 | SESE |
| K973199 | AMSINO SUCTION CATHETER | Amsino Intl., Inc. | Sep 10, 1997 | SESE |
| K961707 | TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM | Sorenson Critical Care | Mar 11, 1997 | SESE |
| K964369 | TRACH CARE SET WITH MICROBAN | Ballard Medical Products | Feb 11, 1997 | SESE |
| K960488 | NEO 2 LINE SUCTION SYSTEM | Alcove Medical, Inc. | Apr 26, 1996 | SESE |
| K955831 | ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM | Sherwood Medical Co. | Mar 28, 1996 | SESE |
| K955645 | CATH-GUIDE | Hudson Respiratory Care, Inc. | Mar 12, 1996 | SESE |
| K952396 | REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION | Contour Fabricators of Florida, Inc. | Aug 15, 1995 | SESE |
| K952395 | REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION | Contour Fabricators of Florida, Inc. | Aug 15, 1995 | SESE |
| K953226 | PULM O2 SUCTION CATHETER TRAYS | Premium Plastics, Inc. | Aug 8, 1995 | SESE |
| K951506 | SUCTION CATHETER KIT, STERILE, SINGLE-USE | Trinity Laboratories, Inc. | Jul 3, 1995 | SESE |
| K945994 | DUAL PURPOSE CATHETER | Universal Medical Products, Inc. | Jun 21, 1995 | SESE |
| K951745 | CONNECTING TUBE | Vital Signs, Inc. | May 30, 1995 | SESE |
| K945950 | TRIGUARD(TM) SUCTION SYSTEM | Vital Signs, Inc. | Dec 27, 1994 | SESE |
| K944251 | KENDALL MODU-VAC CLOSED SUCTION SYSTEM | Kendall Healthcare Products Co. Div.Of Tyco Health | Sep 21, 1994 | SESE |
| K935600 | TRACHEAL SUCTION CATHETER | Puritas Health Care, Inc. | May 10, 1994 | SESK |
Top Applicants
- Sherwood Medical Co. — 7 clearances
- Ballard Medical Products — 5 clearances
- Ackrad Laboratories — 4 clearances
- American Pharmaseal Div. Ahsc — 4 clearances
- Concord Laboratories, Inc. — 3 clearances
