SAFE-CONNECT VIAL DISPENSING SPIKE— 510(k) K970789

Substantially Equivalent

Faulding Medical Device Co.

FDA 510(k) clearance K970789 for SAFE-CONNECT VIAL DISPENSING SPIKE, Substantially Equivalent on 1997-05-01. Applicant: Faulding Medical Device Co..

Clearance details

Applicant: Faulding Medical Device Co.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 1997-03-04
Decision date: 1997-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.