BYY · Tube, Aspirating, Flexible, Connecting
General Hospital · 21 CFR 880.6740 · Class 2
Overview
| Product Code | BYY |
|---|---|
| Device Name | Tube, Aspirating, Flexible, Connecting |
| Regulation | 21 CFR 880.6740 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Recent Cleared Devices (20 of 24)
Showing 20 most recent of 24 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K960616 | VITAFLOW SUCTION/ASPIRATION TUBING SET | Vital Concepts, Inc. | May 6, 1996 | SESE |
| K960218 | CONNECTING TUBING | Custom Pack Reliability | Mar 28, 1996 | SESE |
| K955151 | MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR | Bio-Medical Devices, Inc. | Jan 24, 1996 | SESE |
| K955149 | MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL | Bio-Medical Devices, Inc. | Jan 24, 1996 | SESE |
| K955150 | MAXI-FLOW | Bio-Medical Devices, Inc. | Jan 23, 1996 | SESE |
| K922989 | WILTEK IRRIGAITON/ASPIRATION TUBE SET | Wiltek Medical, Inc. | Feb 15, 1994 | SESE |
| K911586 | GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC) | Megadyne Medical Products, Inc. | Jul 2, 1991 | SESE |
| K901761 | STERILE SUCTION TUBING SET | Acacia Laboratories, Inc. | May 7, 1990 | SESE |
| K873463 | VAN DELLEN ASPIRATING TUBING | Van Dellen, Ltd. | Nov 23, 1987 | SESE |
| K853296 | EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN | Parexel Intl. Corp. | Aug 15, 1985 | SESE |
| K843470 | PHARMA-PLAST CONNECTING TUBE TYPE SUCT- | Zimmar Consulting , Ltd. | Nov 16, 1984 | SESE |
| K832865 | FLEX BUBBLE TUBING | Sheridan Catheter Corp. | Sep 29, 1983 | SESE |
| K832398 | DYNACOR CONNECTING TUBING | Medline Industries, Inc. | Aug 24, 1983 | SESE |
| K831920 | PLASTIC TUBING CONNECTORS | Polymer Technology Corp. | Jul 19, 1983 | SESE |
| K821703 | MGN CONDUCTIVE CONNECTING TUBE, STERILE | Mgn Medical Manufacturing, Inc. | Jun 22, 1982 | SESE |
| K820371 | PLASTIC CONNECTORS | American Pharmaseal Div. Ahsc | Apr 1, 1982 | SESE |
| K820412 | AM. PH. STERILE PLASTIC CONNECTING TUBES | American Pharmaseal Div. Ahsc | Mar 31, 1982 | SESE |
| K813228 | CONNECTING TUBE | Northern Medical Industries | Nov 27, 1981 | SESE |
| K811541 | MGN CONNECTING TUBE | Mgn Medical Manufacturing, Inc. | Jun 18, 1981 | SESE |
| K800235 | ABCO CONNECTING TUBES PRECUT LENGTHS | Abco Dealers, Inc. | Feb 26, 1980 | SESE |
Top Applicants
- Bio-Medical Devices, Inc. — 3 clearances
- American Pharmaseal Div. Ahsc — 2 clearances
- Mgn Medical Manufacturing, Inc. — 2 clearances
- Snyder Laboratories, Inc. — 2 clearances
- Abco Dealers, Inc. — 1 clearance
