Chrysalis Intelligence · Product Codes · PND

PND · Midline Catheter

General Hospital · 4 clearances · 4 unique sponsors

Device class
Class II
Regulation 880.5200
Total clearances
4
2021-08-27 → 2025-12-18
Last 12 months
1
Unique sponsors
4
Definition

What is Midline Catheter

The catheter is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days.
Medical specialty
General Hospital
Review panel
HO
Regulation number
880.5200
Implant
N
Life-sustain / support
N
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
Terumo Medical Products (Hangzhou) Co., Ltd. 1 1 2025-12-18
Arrow International, LLC Subsidiary of Teleflex Incorporated 1 0 2022-09-02
C.R. Bard, Inc. 1 0 2022-05-13
Piper Access, LLC 1 0 2021-08-27
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
36000 CPT — High Introducer/sheath for central/peripheral vascular access; midline catheter placement standard
36410 CPT — High Venipuncture, accessing established central or peripheral catheter; midline catheter use
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-12-18 K252402 Terumo Medical Products (Hangzhou) Co., Ltd. Midline Catheter
2022-09-02 K213855 Arrow International, LLC Subsidiary of Teleflex Incorporated Arrow Pressure Injectable Midline Catheter
2022-05-13 K213203 C.R. Bard, Inc. Provena(TM) Midline Catheter
2021-08-27 K210047 Piper Access, LLC Stiletto Extended Dwell Catheter