ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm— 510(k) K170958

Substantially Equivalent

Tricol Biomedical, Inc.

FDA 510(k) clearance K170958 for ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm, Substantially Equivalent on 2017-08-29. Applicant: Tricol Biomedical, Inc..

Clearance details

Applicant: Tricol Biomedical, Inc.
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 2017-03-31
Decision date: 2017-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

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.