Performer Introducer
FDA 510(k) clearance K171999 · decided 2017-07-31
Clearance details
- K-number
- K171999
- Device name
- Performer Introducer
- Applicant
- Cook Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2017-07-03
- Decision date
- 2017-07-31
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- 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 |
|---|---|---|
| Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-R recall (Z-1786-2025) | Cook Incorporated | 2025-05-16 |
| Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G2 recall (Z-0045-2025) | Cook Incorporated | 2024-10-09 |
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 |