Chrysalis Intelligence · Product Codes · MPB

MPB · Catheter, Hemodialysis, Non-Implanted

Gastroenterology, Urology · 4 clearances · 4 unique sponsors

Device class
Class II
Regulation 876.5540
Total clearances
4
2020-01-17 → 2025-08-12
Last 12 months
0
Unique sponsors
4
Medical specialty
Gastroenterology, Urology
Review panel
GU
Regulation number
876.5540
Implant
N
Life-sustain / support
Y
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Medical Components, Inc. 1 0 2025-08-12
Health Line International Corporation 1 0 2020-12-24
Covidien, LLC 1 0 2020-01-17
Medical Components, Inc. (dba MedComp) 1 0 2020-04-23
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.

CodeTypeDescriptionConfidenceRationale
A4721 HCPCS Dialysate solution, any concentration of dextrose, fluid volume greater than 999 cc but less than or equal to 1999 cc, for peritoneal dialysis ✓ CMS-verified description High Dialysis access system (catheter) for hemodialysis, each
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-08-12 K250836 Medical Components, Inc. 14F Duo-Flow® Side X Side Double Lumen Catheter
2020-12-24 K200426 Health Line International Corporation Acute Dual Lumen Hemodialysis Catheter
2020-04-23 K192807 Medical Components, Inc. (dba MedComp) Duo-Flow Side x Side Double Lumen Catheter
2020-01-17 K192302 Covidien, LLC Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter