The following data is part of a premarket notification filed by Edwards Lifesciences Research Medical with the FDA for 18 Fr. Rmi Arterial Perfusion Cannula Ii, 20 Fr. Rmi Arterial Perfusion Cannula Ii.
| Device ID | K073559 |
| 510k Number | K073559 |
| Device Name: | 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II |
| Classification | Cannula, Catheter |
| Applicant | EDWARDS LIFESCIENCES RESEARCH MEDICAL 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Contact | John W Nicholson |
| Correspondent | John W Nicholson EDWARDS LIFESCIENCES RESEARCH MEDICAL 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Product Code | DQR |
| CFR Regulation Number | 870.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-19 |
| Decision Date | 2008-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103180589 | K073559 | 000 |
| 00690103180572 | K073559 | 000 |
| 00690103180565 | K073559 | 000 |
| 00690103180558 | K073559 | 000 |