The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Retroflex Dilator Kit.
| Device ID | K093554 |
| 510k Number | K093554 |
| Device Name: | RETROFLEX DILATOR KIT |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Jason K Lyon |
| Correspondent | Jason K Lyon EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-17 |
| Decision Date | 2010-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103192391 | K093554 | 000 |