Roadrunner PC Wire Guide, Olcott Torque Device
FDA 510(k) clearance K182985 · decided 2019-07-22
Clearance details
- K-number
- K182985
- Device name
- Roadrunner PC Wire Guide, Olcott Torque Device
- Applicant
- Cook Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2018-10-29
- Decision date
- 2019-07-22
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bloomington, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cook Incorporated
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 |
|---|---|---|
| Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G0960 recall (Z-1838-2022) | Cook Incorporated | 2022-09-28 |
| Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914 recall (Z-1839-2022) | Cook Incorporated | 2022-09-28 |
| Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G0 recall (Z-1840-2022) | Cook Incorporated | 2022-09-28 |
| Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 recall (Z-1841-2022) | Cook Incorporated | 2022-09-28 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S005) | Cook Incorporated | 2009-04-02 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S006) | Cook Incorporated | 2009-03-05 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S004) | Cook Incorporated | 2008-05-08 |
| COOK CHORIONIC VILLUS SAMPLING (CVS) SET (P900007/S002) | Cook Incorporated | 2000-06-12 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S001) | Cook Incorporated | 1998-07-08 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007) | Cook Incorporated | 1994-09-30 |