DeviceClearance

Product code DSP— Cardiovascular

SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER

Classification name
System, Balloon, Intra-Aortic And Control
Device class
Class 2
Regulation
21 CFR 870.3535
Advisory panel
Cardiovascular
Total cleared
162
First cleared
Most recent

Market context for product code DSP

FDA has cleared 162 devices under product code DSP between 1976 and 2025, filed by 22 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 DSP

Adverse events under product code DSP

product code DSP
Death
317
Injury
566
Malfunction
36,831
Other
4
Total
37,718

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 DSP

1–100 of 162

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