MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130— 510(k) K040552

Substantially Equivalent

Cryocor, Inc.

FDA 510(k) clearance K040552 for MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130, Substantially Equivalent on 2004-05-28. Applicant: Cryocor, Inc..

Clearance details

Applicant: Cryocor, Inc.
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2004-03-02
Decision date: 2004-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.