SERAGARD VASCULAR ACCESS DEVICE— 510(k) K963595

Substantially Equivalent

Cutting Edge Technologies, Inc.

FDA 510(k) clearance K963595 for SERAGARD VASCULAR ACCESS DEVICE, Substantially Equivalent on 1997-01-06. Applicant: Cutting Edge Technologies, Inc..

Clearance details

Applicant: Cutting Edge Technologies, Inc.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 1996-09-09
Decision date: 1997-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

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Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.