The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Steerable Retrograde Cardioplegia Cannula With And Without Duraflo Treatment, Models Srco14mib, Diisrco14mib.
| Device ID | K001565 |
| 510k Number | K001565 |
| Device Name: | STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | EDWARDS LIFESCIENCES, LLC. 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Contact | John W Smith |
| Correspondent | John W Smith EDWARDS LIFESCIENCES, LLC. 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-19 |
| Decision Date | 2000-08-10 |