510(k) clearance
FlowXL® System: FlowXL Flowmeter and compatible Flowprobes and Flowsensors
- 510(k) number
- K261714
- Applicant
- Transonic Systems, Inc.
- Decision date
- Oct 27, 2026
- Date received
- May 26, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- DPW
- Device type
- Flowmeter, Blood, Cardiovascular
- Device class
- Class II
- Regulation
- 21 CFR 870.2100
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Ithaca, NY, US