BZA · Connector, Airway (Extension)
Anesthesiology · 21 CFR 868.5810 · Class 1
Overview
| Product Code | BZA |
|---|---|
| Device Name | Connector, Airway (Extension) |
| Regulation | 21 CFR 868.5810 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Recent Cleared Devices (20 of 94)
Showing 20 most recent of 94 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K083702 | TRACH-ASSIST | Mergenet Medical | Mar 5, 2009 | SESE |
| K954383 | SURELOC CIRCUIT CONNECTOR | Polamedco, Inc. | Dec 22, 1995 | SESE |
| K954197 | DISPOSABLE FLEX TUBE | Engstrom Medical | Oct 26, 1995 | SESE |
| K953786 | UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS | Unicor, Inc. | Sep 19, 1995 | SESE |
| K952824 | NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR | Intertex Medical, Inc. | Jul 20, 1995 | SESE |
| K951345 | DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING | Catheter Research, Inc. | Apr 14, 1995 | SESE |
| K944532 | PRIMA, INC. VENTILATOR HOSES | Prima, Inc. | Dec 2, 1994 | SESE |
| K944535 | PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS | Prima, Inc. | Nov 29, 1994 | SESE |
| K944534 | PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS | Prima, Inc. | Nov 29, 1994 | SESE |
| K942392 | AIRWAY CONNECTOR WITH FLEX TUBE | Mallinckrodt Medical | Aug 22, 1994 | SESE |
| K941026 | THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR | Thayer Medical Corp. | Aug 18, 1994 | SESE |
| K940793 | DOUBLE TRACH SWIVEL CONNECTOR | Seven Harvest Intl. Import & Export | Jul 1, 1994 | SESE |
| K940544 | DOUBLE TRACH SEIVEL CONNECTOR | Fvtnks | Apr 19, 1994 | SESE |
| K935821 | DOUBLE TRACH SWIVEL CONNECTOR | Nutec, Inc. | Jan 14, 1994 | SESE |
| K931800 | MAG CONNECTORS AND AIRWAY EXTENSIONS | Mag, Inc. | May 19, 1993 | SESE |
| K931345 | CONNECTORS AND AIRWAY EXTENSIONS | Precision Med Products, Ltd. | Apr 23, 1993 | SESE |
| K931216 | CONNECTORS AND AIRWAY EXTENSIONS | Teknor Medical Products, Inc. | Apr 23, 1993 | SESE |
| K931038 | CONNECTORS AND AIRWAY EXTENSIONS | Med-Plastics Intl., Inc. | Apr 8, 1993 | SESE |
| K931036 | CONNECTORS AND AIRWAY EXTENSIONS | Life Shield Healthcare Products, Inc. | Apr 8, 1993 | SESE |
| K925263 | MERIDIAN MEDICAL SYSTEMS CONNECTORS & AIRWAY EXT | Merit Medical Systems, Inc. | Feb 2, 1993 | SESE |
Top Applicants
- Airlife, Inc. — 11 clearances
- Dhd Medical Products Div. Diemolding Corp. — 8 clearances
- Intersurgical, Inc. — 4 clearances
- Prima, Inc. — 3 clearances
- Intertech/Ohio — 3 clearances
