Device class
Class II
Regulation 870.1340
Total clearances
5
2022-03-10 → 2026-01-07
Definition
What is Reprocessed Catheter Introducer
Introduce various cardiovascular catheters into the heart and cardiovascular system
Classification details
Medical specialty
Cardiovascular
Regulation number
870.1340
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 |
| 36016 |
CPT
|
— |
High
|
Catheter introducer for cardiovascular procedures; reprocessed introducer standard for angiography/intervention |
| 92998 |
CPT
|
— |
Medium
|
Interventional procedures with catheter introducer/sheath for cardiac access |
Pulse
Most recent 510(k) clearances