The following data is part of a premarket notification filed by Ichor Vascular, Inc. with the FDA for The Ichor Panacea Vascular Embolectomy Catheter System.
| Device ID | K182167 |
| 510k Number | K182167 |
| Device Name: | The ICHOR Panacea Vascular Embolectomy Catheter System |
| Classification | Catheter, Embolectomy |
| Applicant | ICHOR Vascular, Inc. 2865 N Reynolds Rd Suite 220A Toledo, OH 43615 |
| Contact | Jeff Blair |
| Correspondent | Angela Mallery NAMSA 400 Highway 169 South, Suite 500 Minneapolis, MN 55426 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-10 |
| Decision Date | 2018-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B729ICH7FR0 | K182167 | 000 |