RAIN Sheath™ Tibial Pedal Introducer
FDA 510(k) clearance K230704 · decided 2023-04-24
Clearance details
- K-number
- K230704
- Device name
- RAIN Sheath™ Tibial Pedal Introducer
- Applicant
- Cordis US Corp
- Decision
- Substantially Equivalent
- Date received
- 2023-03-14
- Decision date
- 2023-04-24
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Miami Lakes, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PALMAZ MULLINS XD Pulmonary Stent (P220004/S002) | Cordis US Corp | 2024-09-05 |
| PALMAZ MULLINS XD Pulmonary Stent (P220004/S001) | Cordis US Corp | 2023-11-02 |
| PALMAZ MULLINS XD Pulmonary Stent (P220004) | Cordis US Corp | 2023-07-21 |