Heli-FX EndoAnchor System— 510(k) K182957
Substantially EquivalentMedtronic Vascular, Inc.
FDA 510(k) clearance K182957 for Heli-FX EndoAnchor System, Substantially Equivalent on 2018-11-21. Applicant: Medtronic Vascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic Vascular, Inc.
- Product code
- Code OTD
- Device class
- Class 2
- Regulation
- 21 CFR 870.3460
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Santa Rosa, CA, US
Recent devices under product code OTD
view all- K171427 — Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette
- K141041 — APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE
- K140036 — APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH
- K130677 — APTUS HELI-FX AORTIC SECUREMENT SYSTEM
- K121168 — APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH
More clearances from Medtronic Vascular, Inc.
view allAdverse events under product code OTD
product code OTD- Death
- 31
- Injury
- 172
- Total
- 203
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.