DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT
FDA 510(k) clearance K120988 · decided 2012-07-25
Clearance details
- K-number
- K120988
- Device name
- DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-04-02
- Decision date
- 2012-07-25
- Days to decision
- 114 days
- Clearance type
- Special
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312 recall (Z-3128-2024) | Medtronic Perfusion Systems | 2024-09-12 |
| Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass p recall (Z-0908-2013) | Medtronic Inc. Cardiac Rhythm Disease Management | 2013-03-05 |
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|---|---|---|
| SynchroMed Infusion System; Ascenda Intrathecal Catheters (P860004/S455) | Medtronic, Inc. | 2025-12-22 |
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| Activa Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense (P960009/S524) | Medtronic, Inc. | 2025-12-08 |