DeviceClearance

Product code DTL— Cardiovascular

ADAPTERS WITH X-COATING

Classification name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device class
Class 2
Regulation
21 CFR 870.4290
Advisory panel
Cardiovascular
Total cleared
137
First cleared
Most recent

Market context for product code DTL

FDA has cleared 137 devices under product code DTL between 1976 and 2015, filed by 83 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

last 15 years

Top applicants under product code DTL

Adverse events under product code DTL

product code DTL
Malfunction
770
Total
770

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 DTL

1–100 of 137

Data sourced from openFDA. This site is unofficial and independent of the FDA.