FDA product code OTD: Endovascular Suturing System
OTD is the FDA product code for endovascular suturing system. It is a Class II device, regulated under 21 CFR 870.3460 and reviewed by the Cardiovascular panel. FDA has cleared 6 510(k) submissions under OTD, from 3 different applicants. The average 510(k) review took 42 days (median 30). 1 De Novo request was granted under it. FDA has posted 1 recall for OTD devices.
Definition
Provides fixation and sealing between and endovascular graft and the native artery.
Classification
| Field | Value |
|---|---|
| Device name | Endovascular Suturing System |
| Device class | Class II |
| Regulation | 21 CFR 870.3460 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for OTD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 29 |
| 2018 | 1 | 28 |
Compare with all 510(k) review times · Search every OTD clearance
Top OTD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aptus Endosystems, Inc. | 3 | 2014-02-06 |
| Medtronic Vascular, Inc. | 2 | 2018-11-21 |
| Aptus Endosystems | 1 | 2014-05-16 |
Most recent OTD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K182957 | Medtronic Vascular, Inc. | Heli-FX EndoAnchor System | 2018-11-21 | 28 |
| K171427 | Medtronic Vascular, Inc. | Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette | 2017-06-13 | 29 |
| K141041 | Aptus Endosystems | APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE | 2014-05-16 | 23 |
| K140036 | Aptus Endosystems, Inc. | APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH | 2014-02-06 | 30 |
| K130677 | Aptus Endosystems, Inc. | APTUS HELI-FX AORTIC SECUREMENT SYSTEM | 2013-04-12 | 30 |
Recalls for OTD devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-09-13.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code OTD?
OTD is the FDA product code for endovascular suturing system. It is a Class II device, regulated under 21 CFR 870.3460 and reviewed by the Cardiovascular panel.
What device class is OTD?
Class II, regulation 21 CFR 870.3460. Typical premarket route: 510(k).
How long does a 510(k) take for product code OTD?
Across 6 cleared submissions the average was 42 days from receipt to decision (median 30).
Which companies have the most OTD clearances?
Aptus Endosystems, Inc. (3); Medtronic Vascular, Inc. (2); Aptus Endosystems (1).
Have OTD devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-09-13.
Next steps
- Run an FDA pathway report with predicate devices for product code OTD
- Run a recall and safety report across every OTD manufacturer
- Watch product code OTD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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