MODIFICATION TO BRAIDED GUIDING INTRODUCER— 510(k) K013202

Substantially Equivalent

Thomas Medical Products, Inc.

FDA 510(k) clearance K013202 for MODIFICATION TO BRAIDED GUIDING INTRODUCER, Substantially Equivalent on 2001-10-23. Applicant: Thomas Medical Products, Inc..

Clearance details

Applicant: Thomas Medical Products, Inc.
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2001-09-25
Decision date: 2001-10-23
Decision: Substantially Equivalent
Clearance type: Special
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.