# K211121: Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit

- Pathway: 510(k) (Traditional)
- Applicant: Intera Oncology, Inc.
- Decided: Oct 14, 2021 after 182 days
- Product code: PTI (Non-Coring (Huber) Needle)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K001901 (2000). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200463: Huber Needle Infusion Set, Safety Huber Needle Infusion Set, Jiangsu Caina Medical Co.,Ltd (2021) Summary page 4.

## Indications for use
The Intera Non-coring (Huber) Needles (Refill Needles and Special Bolus Needles) and OR Prep Kit are indicated for use with the Intera implanted infusion pumps to administer infusate solutions. Specifically, the Refill Needles are indicated for emptying and refilling the reservoir of an Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump; the Special Bolus Needles are indicated for delivering bolus injections or infusions through an Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump; the OR Prep Kit is used to prepare the Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump prior to implantation.

Source page: https://510kreport.com/device/K211121
Methodology: https://510kreport.com/methodology