REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT— 510(k) K951843

Substantially Equivalent

Future Medical Systems, Inc.

FDA 510(k) clearance K951843 for REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT, Substantially Equivalent on 1995-07-14. Applicant: Future Medical Systems, Inc..

Clearance details

Applicant: Future Medical Systems, Inc.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 1995-04-20
Decision date: 1995-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York City, NY, US

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.