FDA product code DTH: Suture, Cardiovascular
DTH is the FDA product code for suture, cardiovascular. It is a Class III device, reviewed by the General and Plastic Surgery panel. Devices under DTH reach the market by PMA; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for DTH devices.
Classification
| Field | Value |
|---|---|
| Device name | Suture, Cardiovascular |
| Device class | Class III |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for DTH devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-03-30.
Frequently asked questions
What is FDA product code DTH?
DTH is the FDA product code for suture, cardiovascular. It is a Class III device, reviewed by the General and Plastic Surgery panel.
What device class is DTH?
Class III. Typical premarket route: PMA.
Have DTH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2011-03-30.
Next steps
- Run an FDA pathway report with predicate devices for product code DTH
- Run a recall and safety report across every DTH manufacturer
- Watch product code DTH 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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