White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter
FDA 510(k) clearance K162448 · decided 2017-05-26
Clearance details
- K-number
- K162448
- Device name
- White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter
- Applicant
- Cook Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2016-09-01
- Decision date
- 2017-05-26
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bloomington, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing ca recall (Z-1935-2026) | Cook Incorporated | 2026-05-01 |
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 |