RUSCH ENDOBRONCHIAL TUBE SETS
FDA 510(k) clearance K951091 · decided 1995-06-08
Clearance details
- K-number
- K951091
- Device name
- RUSCH ENDOBRONCHIAL TUBE SETS
- Applicant
- Rusch Intl.
- Decision
- Substantially Equivalent
- Date received
- 1995-03-09
- Decision date
- 1995-06-08
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- BTS
- Device class
- 2
- Regulation number
- 868.5720
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Jeffrey, NH, 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 |
|---|---|---|
| RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION (K953963) | Rusch, Inc. | 1995-11-27 |
| MODIFIED ENDOBRONCHIAL TUBE (K902116) | Concord/Portex | 1990-08-03 |
| ENDOBRONCHIAL TWIN LUMEN TUBE (K834565) | Portex, Inc. | 1984-01-17 |
| BRONCHOSCOPY TUBE W/ULTRA LOCUFF (K833297) | Surgitek | 1983-12-27 |
| BRONCHO-CATH (K771219) | Mallinckrodt Critical Care | 1977-08-04 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bronchial Double Lumen Tube Set (Left), Sterile recall (Z-2407-2015) | Teleflex, Inc. | 2015-08-18 |
| Bronchial Double Lumen Tube Set (Right), Sterile recall (Z-2408-2015) | Teleflex, Inc. | 2015-08-18 |
| Bronchial One Lumen Tube - Left recall (Z-2409-2015) | Teleflex, Inc. | 2015-08-18 |
| Bronchial One Lumen Tube - Right recall (Z-2410-2015) | Teleflex, Inc. | 2015-08-18 |
| Carlens Bronchial Double Lumen Tube Set (Left) Sterile recall (Z-2411-2015) | Teleflex, Inc. | 2015-08-18 |
| Tracheopart Set (Left), Sterile recall (Z-2412-2015) | Teleflex, Inc. | 2015-08-18 |
| Tracheopart Set (Right), Sterile recall (Z-2413-2015) | Teleflex, Inc. | 2015-08-18 |
| White Bronchial Double Lumen Tube Set (Right) Sterile recall (Z-2414-2015) | Teleflex, Inc. | 2015-08-18 |
| Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile recall (Z-2415-2015) | Teleflex, Inc. | 2015-08-18 |
| Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube set is indicated f recall (Z-1231-2014) | Teleflex Medical | 2014-03-19 |