Finesse Injectable PTA Balloon Dilatation Catheter— 510(k) K230263
Substantially EquivalentSumma Therapeutics, LLC
FDA 510(k) clearance K230263 for Finesse Injectable PTA Balloon Dilatation Catheter, Substantially Equivalent on 2023-05-26. Applicant: Summa Therapeutics, LLC. Device class: 2.
Clearance details
- Applicant
- Summa Therapeutics, LLC
- Product code
- Code LIT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Providence, RI, US
Recent devices under product code LIT
view allMore clearances from Summa Therapeutics, LLC
view allAdverse events under product code LIT
product code LIT- Death
- 27
- Injury
- 1,256
- Malfunction
- 12,127
- Total
- 13,410
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 →
Recalls naming K230263
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K230263.
Data sourced from openFDA. This site is unofficial and independent of the FDA.