FLEXCATH STEERABLE SHEATH & DILATOR— 510(k) K070357

Substantially Equivalent

Cryocath Technologies, Inc.

FDA 510(k) clearance K070357 for FLEXCATH STEERABLE SHEATH & DILATOR, Substantially Equivalent on 2007-12-28. Applicant: Cryocath Technologies, Inc..

Clearance details

Applicant: Cryocath Technologies, Inc.
Product code: Code DRA
Advisory panel: Cardiovascular
Date received: 2007-02-07
Decision date: 2007-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Fe, NM, US

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Adverse events under product code DRA

product code DRA

Death: 156
Injury: 3,133
Malfunction: 6,266
Total: 9,555

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.