K233895
- 510(k) number
- K233895
- Device name
- EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B);
- Applicant
- Edwards Lifesciences CA · US
- Product code
- DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmon
- Decision date
- 2024-02-05
- Date received
- 2023-12-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K233895.pdf
Official FDA record: K233895
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.