Product code OTD— Cardiovascular
APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH
- Classification name
- Endovascular Suturing System
- Device class
- Class 2
- Regulation
- 21 CFR 870.3460
- Advisory panel
- Cardiovascular
- Total cleared
- 7
- First cleared
- Most recent
FDA classification definition
“Provides fixation and sealing between and endovascular graft and the native artery.”
Market context for product code OTD
FDA has cleared devices under product code OTD between 2011 and 2018, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2018
- 2017
- 2014
- 2013
- 2012
- 2011
Top applicants under product code OTD
Adverse 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 →
Recent clearances under product code OTD
- K182957 — Heli-FX EndoAnchor System
- 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
- DEN100026 — APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE
Data sourced from openFDA. This site is unofficial and independent of the FDA.