APRO 35 Swift Catheter— 510(k) K262392
Substantially EquivalentAlembic, LLC
FDA 510(k) clearance K262392 for APRO 35 Swift Catheter, Substantially Equivalent on 2026-08-12. Applicant: Alembic, LLC. Device class: 2.
Summary
Alembic's APRO 35 Swift Catheter is filed under product code DQY, percutaneous catheters. The record gives no further description.
Class II, 21 CFR 870.1250. The Neurology review panel handled it as a Special 510(k), though the record lists Cardiovascular as the classification panel.
Alembic filed from Mountain View, California. The decision came 29 calendar days after FDA received it (July 14 to August 12, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Alembic, LLC
- Product code
- Product code DQY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mountain View, CA, US
Recent devices under product code DQY
view allMore clearances from Alembic, LLC
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.