The following data is part of a premarket notification filed by Endarx, Inc. with the FDA for Endohelix Endarterectomy Device.
| Device ID | K032105 |
| 510k Number | K032105 |
| Device Name: | ENDOHELIX ENDARTERECTOMY DEVICE |
| Classification | Stripper, Artery, Intraluminal |
| Applicant | ENDARX, INC. 3270 ALPINE ROAD Portola Valley, CA 94028 |
| Contact | Scott Adams |
| Correspondent | Scott Adams ENDARX, INC. 3270 ALPINE ROAD Portola Valley, CA 94028 |
| Product Code | DWX |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-08 |
| Decision Date | 2003-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663102587 | K032105 | 000 |