ISAAC Neurovascular Navigation Catheter— 510(k) K261808
Substantially EquivalentMicrovention Inc. d/b/a Terumo Neuro
FDA 510(k) clearance K261808 for ISAAC Neurovascular Navigation Catheter, Substantially Equivalent on 2026-06-30. Applicant: Microvention Inc. d/b/a Terumo Neuro. Device class: 2.
Summary
The ISAAC Neurovascular Navigation Catheter is from Microvention, doing business as Terumo Neuro, and is filed under QJP, percutaneous neurovasculature catheters. The record doesn't say what "ISAAC" refers to or give dimensions.
Class II, 21 CFR 870.1250. The Neurology review panel handled it as a Special 510(k); the record lists Cardiovascular as the classification panel.
Microvention filed from Aliso Viejo, California. The decision came 29 calendar days after receipt (June 1 to June 30, 2026).
Clearance details
- Applicant
- Microvention Inc. d/b/a Terumo Neuro
- 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
- Special
- Location
- Aliso Viejo, CA, US
Recent devices under product code QJP
view allMore clearances from Microvention Inc. d/b/a Terumo Neuro
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.