RUSCH POLYFLEX STENT KIT
FDA 510(k) clearance K013266 · decided 2001-11-27
Clearance details
- K-number
- K013266
- Device name
- RUSCH POLYFLEX STENT KIT
- Applicant
- Rusch Intl.
- Decision
- Substantially Equivalent
- Date received
- 2001-10-01
- Decision date
- 2001-11-27
- Days to decision
- 57 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
- Jaffrey, 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 POLYFLEX STENT KIT (K982614) | Rusch Intl. | 1998-12-04 |
| RUSCH TRACHEAL BRONCHIAL Y STENT (K953593) | Rusch, Inc. | 1995-10-13 |
Recalls involving this device
No recalls on record reference this clearance.