18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II
FDA 510(k) clearance K073559 · decided 2008-01-31
Clearance details
- K-number
- K073559
- Device name
- 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II
- Applicant
- Edwards Lifesciences Research Medical
- Decision
- Substantially Equivalent
- Date received
- 2007-12-19
- Decision date
- 2008-01-31
- Days to decision
- 43 days
- Clearance type
- Special
- Product code
- DQR
- Device class
- 2
- Regulation number
- 870.1300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Midvale, UT, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
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| MODIFIED SHILEY FEMORAL VENOUS CANNULA (K894784) | Shiley, Inc. | 1990-03-28 |
| RMI ARTERIAL PERFUSION CANNULA (K894243) | Research Medical, Inc. | 1989-09-19 |
| HARBORIN CENTRAL VENOUS CATHETER (K884628) | Harbor Medical Devices, Inc. | 1989-05-15 |
| DAIG COLLAPSIBLE STERILE SLEEVE (K884478) | Daig Corp. | 1989-02-22 |
| TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER (K884375) | Argon Medical Corp. | 1989-01-11 |
| ASK-300 (K882977) | Medical Repackers Co. | 1989-01-05 |
| HARBOR CENTRAL VENOUS CATHETER (K881884) | Harbor Medical Devices, Inc. | 1988-07-28 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalo recall (Z-2080-2025) | Edwards Lifesciences, LLC | 2025-07-10 |
| Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalo recall (Z-2081-2025) | Edwards Lifesciences, LLC | 2025-07-10 |