APRO 88 Catheter— 510(k) K261938
Substantially EquivalentAlembic, LLC
FDA 510(k) clearance K261938 for APRO 88 Catheter, Substantially Equivalent on 2026-10-06. Applicant: Alembic, LLC. Device class: 2.
Summary
The APRO 88 Catheter from Alembic is filed under QJP, percutaneous neurovasculature catheters. The record doesn't say what "88" refers to or give dimensions.
Class II, 21 CFR 870.1250. The Neurology review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
Alembic filed from Mountain View, California. Review took 118 days (June 10 to October 6, 2026).
Clearance details
- Applicant
- Alembic, LLC
- Product code
- Product code QJP
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mountain View, CA, US
Recent devices under product code QJP
view allMore clearances from Alembic, LLC
view allAdverse events under product code QJP
product code QJP- Death
- 43
- Injury
- 233
- Malfunction
- 1,010
- Total
- 1,286
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.