The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Retrograde Coronary Sinus Cardioplegia Catheter, Retrograde Cardioplegia Catheter, Retrograde Cardioplegia Cannula.
| Device ID | K123187 |
| 510k Number | K123187 |
| Device Name: | RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | EDWARDS LIFESCIENCES, LLC. 12050 Lone Peak Pkwy Draper, UT 84020 |
| Contact | Karen Jones |
| Correspondent | Karen Jones EDWARDS LIFESCIENCES, LLC. 12050 Lone Peak Pkwy Draper, UT 84020 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-11 |
| Decision Date | 2013-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103153996 | K123187 | 000 |
| 00690103034370 | K123187 | 000 |
| 00690103034356 | K123187 | 000 |
| 00690103034349 | K123187 | 000 |
| 00690103034332 | K123187 | 000 |
| 00690103034325 | K123187 | 000 |
| 00690103034288 | K123187 | 000 |
| 00690103034271 | K123187 | 000 |
| 00690103034264 | K123187 | 000 |
| 00690103034240 | K123187 | 000 |
| 00690103034233 | K123187 | 000 |
| 00690103034226 | K123187 | 000 |
| 00690103033281 | K123187 | 000 |
| 00690103033007 | K123187 | 000 |
| 00690103034387 | K123187 | 000 |
| 00690103034394 | K123187 | 000 |
| 00690103151725 | K123187 | 000 |
| 00690103151374 | K123187 | 000 |
| 00690103040562 | K123187 | 000 |
| 00690103040555 | K123187 | 000 |
| 00690103038859 | K123187 | 000 |
| 00690103034486 | K123187 | 000 |
| 00690103034479 | K123187 | 000 |
| 00690103034462 | K123187 | 000 |
| 00690103034455 | K123187 | 000 |
| 00690103034448 | K123187 | 000 |
| 00690103034424 | K123187 | 000 |
| 00690103034417 | K123187 | 000 |
| 00690103034400 | K123187 | 000 |
| 00690103032994 | K123187 | 000 |