Dilator Sets
FDA 510(k) clearance K183036 · decided 2018-12-20
Clearance details
- K-number
- K183036
- Device name
- Dilator Sets
- Applicant
- Cook Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2018-11-01
- Decision date
- 2018-12-20
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- DRE
- Device class
- 2
- Regulation number
- 870.1310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bloomington, IN, US
- Third-party review
- No
- Expedited review
- No
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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 |
|---|---|---|
| Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutane recall (Z-1530-2024) | Cook Incorporated | 2024-04-12 |
| Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or c recall (Z-1531-2024) | Cook Incorporated | 2024-04-12 |
| Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneo recall (Z-1532-2024) | Cook Incorporated | 2024-04-12 |
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 |