Definition: 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.
| Device Type ID | 2756 |
| Device Name | Non-coring (huber) Needle |
| Physical State | Sterile Medical Grade Stainless Steel Hollow Needle Which May Be Straight Or Bent At A 90 Degrees, With A Hub That Is Only Compatible With Other Luer Type Devices. The Needle Tip Angles So The Bevel Opening Provides A Clean Entry Into The Port’s Sept |
| Technical Method | A Sterile Non-coring (Huber) Needle Used Under Sterile Conditions To Pierce The Skin Above A Subcutaneous Implanted Intravascular Infusion Port. Once The Port Is Accessed, The Needle Is Pushed Through The Septum Into The Port Reservoir Body That Has |
| Target Area | Various Subcutaneous Locations; Upper Arms, Chest And Abdomen. Indirectly Effects The Central Venous Vascular System By Facilitating The Delivery Of Intravenous Fluids, Medications, Contrast Media And The Withdrawal Of Blood For Laboratory Sampling. |
| Regulation Description | Hypodermic Single Lumen Needle. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5570 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PTI |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2756 |
| Device | Non-coring (huber) Needle |
| Product Code | PTI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hypodermic Single Lumen Needle. |
| CFR Regulation Number | 880.5570 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
B. BRAUN MEDICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
B. BRAUN MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDCOMP (MEDICAL COMPONENTS, INC.) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |