K971968

Substantially Equivalent

SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97)

Applicant
Remington Medical, Inc.
Product code
DSA
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Alpharetta, GA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DSA

product code DSA
Death
2
Total
2

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.