AORTIC ARCH CANNULAS
FDA 510(k) clearance K943934 · decided 1995-06-02
Clearance details
- K-number
- K943934
- Device name
- AORTIC ARCH CANNULAS
- Applicant
- Sorin Group Italia S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 1994-08-12
- Decision date
- 1995-06-02
- Days to decision
- 294 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mirandola, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6 recall (Z-2756-2016) | Sorin Group USA, Inc. | 2016-09-08 |
| AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part recall (Z-2147-2016) | Sorin Group USA, Inc. | 2016-07-08 |
| Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model recall (Z-0813-2016) | Sorin Group USA, Inc. | 2016-02-16 |