The following data is part of a premarket notification filed by Edwards Lifesciences Research Medical with the FDA for Retrograde Cardioplegia Cannula With Duraflo Treatment, Model Dii-rc-014.
Device ID | K991170 |
510k Number | K991170 |
Device Name: | RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014 |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | EDWARDS LIFESCIENCES RESEARCH MEDICAL 6864 SOUTH 300 WEST Midvale, UT 84047 |
Contact | John W Smith |
Correspondent | John W Smith EDWARDS LIFESCIENCES RESEARCH MEDICAL 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 | 1999-04-07 |
Decision Date | 1999-07-02 |
Summary: | summary |