LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension— 510(k) K220691

Substantially Equivalent

Seigla Medical, Inc.

FDA 510(k) clearance K220691 for LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension, Substantially Equivalent on 2022-05-05. Applicant: Seigla Medical, Inc..

Clearance details

Applicant: Seigla Medical, Inc.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2022-03-09
Decision date: 2022-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.