DTHClass III

Suture, Cardiovascular

Unknown

DTH is the FDA product code for Suture, Cardiovascular, a class III device type. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: DTH
Device name: Suture, Cardiovascular
Device class: Class III
Review panel: Unknown
Submission type: PMA
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code DTH.

Recent clearances

Product code DTH

FDA records hold no clearances under product code DTH.

Recent recalls

Product code DTH

Z-2138-2011Mislabeled - a number of units of the product labeled as 4-0 Black Mono Nylon suture product contain a 4-0 Black Braided Silk...Surgical Specialties Corp / initiated 2011-03-30 / 2,628

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)