Armada 14 NC PTA Catheter— 510(k) K252512
Substantially EquivalentABBOTT MEDICAL
FDA 510(k) clearance K252512 for Armada 14 NC PTA Catheter, Substantially Equivalent on 2026-02-13. Applicant: ABBOTT MEDICAL. Device class: 2.
Summary
Abbott Medical's Armada 14 NC PTA Catheter is filed under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal). The record doesn't describe the catheter beyond its name and that code name.
Class II, 21 CFR 870.1250. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).
Abbott Medical filed from Santa Clara, California. FDA found it substantially equivalent 186 calendar days after receipt (August 11, 2025 to February 13, 2026).
Clearance details
- Applicant
- ABBOTT MEDICAL
- Product code
- Product 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
- Santa Clara, CA, US
Recent devices under product code LIT
view allMore clearances from ABBOTT MEDICAL
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.