TRACH-ASSIST
FDA 510(k) clearance K083702 · decided 2009-03-05
Clearance details
- K-number
- K083702
- Device name
- TRACH-ASSIST
- Applicant
- Mergenet Medical
- Decision
- Substantially Equivalent
- Date received
- 2008-12-15
- Decision date
- 2009-03-05
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- BZA
- Device class
- 1
- Regulation number
- 868.5810
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bonita Springs, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SURELOC CIRCUIT CONNECTOR (K954383) | Polamedco, Inc. | 1995-12-22 |
| DISPOSABLE FLEX TUBE (K954197) | Engstrom Medical | 1995-10-26 |
| UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS (K953786) | Unicor, Inc. | 1995-09-19 |
| NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR (K952824) | Intertex Medical, Inc. | 1995-07-20 |
| DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING (K951345) | Catheter Research, Inc. | 1995-04-14 |
| PRIMA, INC. VENTILATOR HOSES (K944532) | Prima, Inc. | 1994-12-02 |
| PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS (K944535) | Prima, Inc. | 1994-11-29 |
| PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS (K944534) | Prima, Inc. | 1994-11-29 |
| AIRWAY CONNECTOR WITH FLEX TUBE (K942392) | Mallinckrodt Medical | 1994-08-22 |
| THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR (K941026) | Thayer Medical Corp. | 1994-08-18 |
| DOUBLE TRACH SWIVEL CONNECTOR (K940793) | Seven Harvest Intl. Import & Export | 1994-07-01 |
| DOUBLE TRACH SEIVEL CONNECTOR (K940544) | Fvtnks | 1994-04-19 |
Recalls involving this device
No recalls on record reference this clearance.