RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION
FDA 510(k) clearance K953963 · decided 1995-11-27
Clearance details
- K-number
- K953963
- Device name
- RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION
- Applicant
- Rusch, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-08-22
- Decision date
- 1995-11-27
- Days to decision
- 97 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 ENDOBRONCHIAL TUBE SETS (K951091) | Rusch Intl. | 1995-06-08 |
| 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
No recalls on record reference this clearance.