DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH— 510(k) K913235

Substantially Equivalent

Davol, Inc.

FDA 510(k) clearance K913235 for DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH, Substantially Equivalent on 1991-10-31. Applicant: Davol, Inc..

Clearance details

Applicant: Davol, Inc.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 1991-07-22
Decision date: 1991-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.