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 |