510(k) clearance
VIVO (9002)
- 510(k) number
- K261886
- Applicant
- Catheter Precision, Inc.
- Decision date
- Oct 30, 2026
- Date received
- Jun 5, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- DQK
- Device type
- Computer, Diagnostic, Programmable
- Device class
- Class II
- Regulation
- 21 CFR 870.1425
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Fort Mill, SC, US