HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19 CM, KIT WITH MICROINTRODUCER— 510(k) K033294

Unknown

C.R. Bard, Inc.

FDA 510(k) clearance K033294 for HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19 CM, KIT WITH MICROINTRODUCER, Unknown on 2003-11-26. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2003-10-14
Decision date: 2003-11-26
Decision: Unknown
Clearance type: Special
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MSD

product code MSD

Death: 67
Injury: 545
Malfunction: 3,661
Total: 4,273

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.