DeviceClearance

Product code DTC— Cardiovascular

ANALYZER, PACER SYSTEM, PSA-5

Classification name
Analyzer, Pacemaker Generator Function
Device class
Class 2
Regulation
21 CFR 870.3630
Advisory panel
Cardiovascular
Total cleared
30
First cleared
Most recent

Market context for product code DTC

FDA has cleared 30 devices under product code DTC between 1976 and 2017, filed by 19 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 DTC

Adverse events under product code DTC

product code DTC
Injury
136
Malfunction
3,400
Total
3,536

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 DTC

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