PATH BGC— 510(k) K260938
Substantially EquivalentCrossroads Neurovascular, Inc.
FDA 510(k) clearance K260938 for PATH BGC, Substantially Equivalent on 2026-04-15. Applicant: Crossroads Neurovascular, Inc.. Device class: 2.
Summary
Crossroads Neurovascular's PATH BGC is filed under product code QJP (Catheter, Percutaneous, Neurovasculature). The record doesn't spell out BGC or describe the device beyond its name and that code name.
Class II, 21 CFR 870.1250. The record lists Cardiovascular as the classification panel, but the Neurology review panel handled this Special 510(k).
Crossroads Neurovascular filed from Lake Forest, California. Review took 26 calendar days (March 20 to April 15, 2026).
Clearance details
- Applicant
- Crossroads Neurovascular, Inc.
- 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
- Lake Forest, CA, US
Recent devices under product code QJP
view allMore clearances from Crossroads Neurovascular, Inc.
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.