SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE— 510(k) K003731

Substantially Equivalent

Thomas Medical Products, Inc.

FDA 510(k) clearance K003731 for SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE, Substantially Equivalent on 2001-04-10. Applicant: Thomas Medical Products, Inc..

Clearance details

Applicant: Thomas Medical Products, Inc.
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2000-12-04
Decision date: 2001-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

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Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.