The following data is part of a premarket notification filed by Medtronic Vascular, Inc. with the FDA for Heli-fx Applier, Heli-fx Guide, Ancillary Endoanchor Cassette.
| Device ID | K171427 |
| 510k Number | K171427 |
| Device Name: | Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette |
| Classification | Endovascular Suturing System |
| Applicant | Medtronic Vascular, Inc. 3850 Brickway Blvd Santa Rosa, CA 95403 |
| Contact | Burt Goodson |
| Correspondent | Burt Goodson 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 | 2017-05-15 |
| Decision Date | 2017-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000025298 | K171427 | 000 |
| 00763000006617 | K171427 | 000 |
| 00763000225971 | K171427 | 000 |
| 00763000225964 | K171427 | 000 |
| 00763000226008 | K171427 | 000 |
| 00763000225995 | K171427 | 000 |
| 00763000225988 | K171427 | 000 |
| 00763000225940 | K171427 | 000 |
| 00763000225933 | K171427 | 000 |
| 00763000006624 | K171427 | 000 |
| 00763000006631 | K171427 | 000 |
| 00763000006648 | K171427 | 000 |
| 00763000025281 | K171427 | 000 |
| 00763000025274 | K171427 | 000 |
| 00763000025267 | K171427 | 000 |
| 00763000025250 | K171427 | 000 |
| 00763000006686 | K171427 | 000 |
| 00763000006679 | K171427 | 000 |
| 00763000006662 | K171427 | 000 |
| 00763000006655 | K171427 | 000 |
| 00763000225957 | K171427 | 000 |