DeviceClearance

Product code DRC— Cardiovascular

MOBICATH TRANSSEPTAL NEEDLE

Classification name
Trocar
Device class
Class 2
Regulation
21 CFR 870.1390
Advisory panel
Cardiovascular
Total cleared
51
First cleared
Most recent

Market context for product code DRC

FDA has cleared 51 devices under product code DRC between 1977 and 2024, filed by 33 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 DRC

Adverse events under product code DRC

product code DRC
Death
28
Injury
412
Total
440

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 DRC

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