Chrysalis Intelligence · Product Codes · MSD

MSD · Catheter, Hemodialysis, Implanted

Gastroenterology, Urology · 9 clearances · 6 unique sponsors

Device class
Class II
Regulation 876.5540
Total clearances
9
2020-03-05 → 2025-05-16
Last 12 months
0
Unique sponsors
6
Medical specialty
Gastroenterology, Urology
Review panel
GU
Regulation number
876.5540
Implant
Y
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
C.R. Bard, Inc. 4 0 2021-07-01
Medical Components Inc (Medcomp) 1 0 2021-09-14
C B Bard, Inc. 1 0 2021-04-02
Bard Peripheral Vascular, Inc. 1 0 2021-06-04
Haolang Medical USA Corporation 1 0 2025-05-16
Medical Components, Inc. (dba MedComp) 1 0 2020-09-03
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
36145 CPT High Standard code for tunneled hemodialysis catheter placement/imaging related to access
E1575 HCPCS Transducer protectors/fluid barriers, for hemodialysis, any size, per 10 ✓ CMS-verified description Medium Hemodialysis catheter supplies code
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-05-16 K241581 Haolang Medical USA Corporation Hemodialysis Catheter
2021-09-14 K210461 Medical Components Inc (Medcomp) End Cap
2021-07-01 K203575 C.R. Bard, Inc. GlidePath Retro Long-Term Hemodialysis Catheter
2021-06-04 K211410 Bard Peripheral Vascular, Inc. GlidePath 13F Long-Term Hemodialysis Catheter
2021-04-02 K203767 C B Bard, Inc. Pristine Long-Term Hemodialysis Catheter
2020-11-18 K202150 C.R. Bard, Inc. GlidePath 7.5F Long-Term Dialysis Catheter
2020-09-03 K202176 Medical Components, Inc. (dba MedComp) Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes
2020-06-22 K200627 C.R. Bard, Inc. GlidePath 10F Long-Term Dialysis Catheter
2020-03-05 K190527 C. R. Bard GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters