Straub Endovascular System
FDA 510(k) clearance K172315 · decided 2018-04-12
Clearance details
- K-number
- K172315
- Device name
- Straub Endovascular System
- Applicant
- Straub Medical AG
- Decision
- Substantially Equivalent
- Date received
- 2017-08-01
- Decision date
- 2018-04-12
- Days to decision
- 254 days
- Clearance type
- Traditional
- Product code
- MCW
- Device class
- 2
- Regulation number
- 870.4875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Wangs, CH
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Straub Medical AG
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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: recall (Z-1244-2025) | Bard Peripheral Vascular Inc | 2025-03-05 |