SoloPath Re-Collapsible Access System
FDA 510(k) clearance K152498 · decided 2016-01-05
Clearance details
- K-number
- K152498
- Device name
- SoloPath Re-Collapsible Access System
- Applicant
- Onset Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2015-09-01
- Decision date
- 2016-01-05
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Onset Medical Corporation
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 |
|---|---|---|
| SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, S recall (Z-1375-2019) | Terumo Medical Corporation | 2019-05-28 |
| Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20 recall (Z-1376-2019) | Terumo Medical Corporation | 2019-05-28 |