FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F— 510(k) K110193

Substantially Equivalent

St. Jude Medical Systems AB

FDA 510(k) clearance K110193 for FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F, Substantially Equivalent on 2011-02-24. Applicant: St. Jude Medical Systems AB.

Clearance details

Applicant: St. Jude Medical Systems AB
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 2011-01-24
Decision date: 2011-02-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Uppsala, SE

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Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

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.