LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension— 510(k) K220691
Substantially EquivalentSeigla 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.. Device class: 2.
Clearance details
- Applicant
- Seigla Medical, Inc.
- Product code
- Code DQY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buffalo, MN, US
Recent devices under product code DQY
view allMore clearances from Seigla Medical, Inc.
view allAdverse 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, through . 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.