DeviceClearance

K020257

Substantially Equivalent

DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S

Applicant
Datascope Corp.
Product code
DSP
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Fairfield, NJ, US
Download summary PDF View on FDA.gov ↗

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 →

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