RUSCH TRACHEAL BRONCHIAL Y STENT
FDA 510(k) clearance K953593 · decided 1995-10-13
Clearance details
- K-number
- K953593
- Device name
- RUSCH TRACHEAL BRONCHIAL Y STENT
- Applicant
- Rusch, Inc.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1995-07-31
- Decision date
- 1995-10-13
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- NYT
- Device class
- 2
- Regulation number
- 878.3720
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Jeffrey, NH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Rusch
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RUSCH POLYFLEX STENT KIT (K013266) | Rusch Intl. | 2001-11-27 |
| RUSCH POLYFLEX STENT KIT (K982614) | Rusch Intl. | 1998-12-04 |
Recalls involving this device
No recalls on record reference this clearance.