Chrysalis Intelligence · Product Codes · PTI

PTI · Non-Coring (Huber) Needle

General Hospital · 8 clearances · 5 unique sponsors

Device class
Class II
Regulation 880.5570
Total clearances
8
2021-04-07 → 2025-11-26
Last 12 months
1
Unique sponsors
5
Definition

What is Non-Coring (Huber) Needle

The non-coring needle (Huber) is utilized to gain access into a subcutaneous implanted intravascular infusion port but can also be used to access other non-vascular implanted devices with similar septums.
Medical specialty
General Hospital
Review panel
HO
Regulation number
880.5570
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
Promisemed Hangzhou Meditech Co., Ltd. 3 0 2025-05-13
Intera Oncology, Inc. 2 0 2022-03-16
Sb-Kawasumi Laboratories, Inc. 1 1 2025-11-26
Jiangsu Caina Medical Co.,Ltd 1 0 2021-04-07
Bard Access Systems, Inc. 1 0 2024-11-27
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
A4224 HCPCS Supplies for maintenance of insulin infusion catheter, per week ✓ CMS-verified description High Non-coring Huber needle for access to implanted vascular infusion port
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-11-26 K252355 Sb-Kawasumi Laboratories, Inc. K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing
2025-05-13 K251138 Promisemed Hangzhou Meditech Co., Ltd. Promisemed Safety Huber Needles
2025-03-14 K243332 Promisemed Hangzhou Meditech Co., Ltd. Promisemed Safety Huber Needles
2024-11-27 K241353 Bard Access Systems, Inc. PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set
2023-06-08 K230715 Promisemed Hangzhou Meditech Co., Ltd. Promisemed Safety Huber Needle
2022-03-16 K213823 Intera Oncology, Inc. Intera Refill Kit
2021-10-14 K211121 Intera Oncology, Inc. Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit
2021-04-07 K200463 Jiangsu Caina Medical Co.,Ltd Huber Needle Infusion Set, Safety Huber Needle Infusion Set