The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe.
| Device ID | K193379 |
| 510k Number | K193379 |
| Device Name: | Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe |
| Classification | Catheter, Embolectomy |
| Applicant | Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
| Contact | Wendy Vera Gonzalez |
| Correspondent | Wendy Vera Gonzalez Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-05 |
| Decision Date | 2020-06-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50690103205133 | K193379 | 000 |
| 50690103205089 | K193379 | 000 |
| 50690103205096 | K193379 | 000 |
| 50690103205102 | K193379 | 000 |
| 50690103205195 | K193379 | 000 |
| 50690103205201 | K193379 | 000 |
| 50690103205218 | K193379 | 000 |
| 50690103205225 | K193379 | 000 |
| 50690103205232 | K193379 | 000 |
| 50690103205249 | K193379 | 000 |
| 50690103205119 | K193379 | 000 |
| 50690103205126 | K193379 | 000 |
| 50690103201784 | K193379 | 000 |