ADROIT GUIDING CATHETER
FDA 510(k) clearance K131225 · decided 2013-05-29
Clearance details
- K-number
- K131225
- Device name
- ADROIT GUIDING CATHETER
- Applicant
- Cordis Corp., A Johnson & Johnson Co.
- Decision
- Substantially Equivalent
- Date received
- 2013-04-30
- Decision date
- 2013-05-29
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cordis Corp.
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 |
|---|---|---|
| Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interve recall (Z-0003-2014) | Cordis Corporation | 2013-10-01 |