DeviceClearance

CrossFAST Integrated Microcatheter Advanced Delivery System— 510(k) K262817

Substantially Equivalent

Vantis Vascular, Inc.

FDA 510(k) clearance K262817 for CrossFAST Integrated Microcatheter Advanced Delivery System, Substantially Equivalent on 2026-09-18. Applicant: Vantis Vascular, Inc.. Device class: 2.

Summary

Vantis Vascular, Inc. submitted the CrossFAST Integrated Microcatheter Advanced Delivery System under product code DQY (Catheter, Percutaneous). The record has nothing on the system beyond its name and code.

Class II, 21 CFR 870.1250. Cardiovascular is both the classification panel and the review panel, and it came in as a Special 510(k). The decision was Substantially Equivalent.

Vantis filed from San Jose, California. The decision came 42 calendar days after receipt (August 7 to September 18, 2026).

Clearance details

Applicant
Vantis Vascular, Inc.
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
San Jose, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse 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.