The following data is part of a premarket notification filed by Medtronic Vascular, Inc. with the FDA for Heli-fx Endoanchor System.
| Device ID | K182957 |
| 510k Number | K182957 |
| Device Name: | Heli-FX EndoAnchor System |
| Classification | Endovascular Suturing System |
| Applicant | Medtronic Vascular, Inc. 3850 Brickway Blvd Santa Rosa, CA 95403 |
| Contact | Janelle Wong Keller |
| Correspondent | Janelle Wong Keller Medtronic Vascular, Inc. 3850 Brickway Blvd Santa Rosa, CA 95403 |
| Product Code | OTD |
| CFR Regulation Number | 870.3460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-24 |
| Decision Date | 2018-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000645182 | K182957 | 000 |
| 00763000645175 | K182957 | 000 |
| 00763000645168 | K182957 | 000 |
| 00763000645151 | K182957 | 000 |
| 00763000645144 | K182957 | 000 |
| 00763000645137 | K182957 | 000 |
| 00763000645120 | K182957 | 000 |
| 00763000645113 | K182957 | 000 |