The following data is part of a premarket notification filed by Surge Cardiovascular with the FDA for Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr.
| Device ID | K170488 |
| 510k Number | K170488 |
| Device Name: | Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | Surge Cardiovascular (Alliant Enterprises DBA Surge Cardiovascular) 333 Bridge Street NW, Suite 1125 Grand Rapids, MI 49504 |
| Contact | Rick Shorey |
| Correspondent | Korina A. Akhondzadeh KARA & Associates 6965 El Camino Real, Suite 105-428 Carlsbad, CA 92009 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-17 |
| Decision Date | 2017-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817278012232 | K170488 | 000 |
| 10817278012225 | K170488 | 000 |
| 10817278012218 | K170488 | 000 |