Device class
—
Regulation —
Total clearances
3
2022-04-08 → 2026-08-06
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 36014 |
CPT
|
— |
Medium
|
Venipuncture for fistula access, though fistula needle not separately billable |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-08-06 |
K253469 |
Mozarc Medical Us, LLC
|
Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM) |
| 2025-08-15 |
K251877 |
JMS North America Corporation
|
JMS CAVEO A.V. Fistula Needle Set |
| 2022-04-08 |
K213015 |
Bain Medical Equipment (Guangzhou) Co., Ltd.
|
DORA Disposable A.V. Fistula Needle Sets |