MC3 Crescent Jugular Dual Lumen Catheter
FDA 510(k) clearance K203409 · decided 2021-05-03
Clearance details
- K-number
- K203409
- Device name
- MC3 Crescent Jugular Dual Lumen Catheter
- Applicant
- Mc3, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-11-19
- Decision date
- 2021-05-03
- Days to decision
- 165 days
- Clearance type
- Traditional
- Product code
- PZS
- Device class
- 2
- Regulation number
- 870.4100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Dexter, MI, 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.
| Record | Firm | Date |
|---|---|---|
| ProtekDuo Veno-Venous Cannula Sets (K232480) | Cardiacassist, Inc. | 2023-10-06 |
| MC3 Jugular Dual Lumen Catheter (K180151) | Mc3 Incorporated | 2018-07-16 |
| MC3 QuickFlow Dual Lumen Catheter (K171610) | Mc3 Incorporated | 2017-11-16 |
Recalls involving this device
No recalls on record reference this clearance.