Data / Medical devices / United States / Intera Oncology

Intera Oncology: FDA-registered device maker in Newton, MA, United States, 2 510(k) clearances and 1 PMA approval

Name: Intera Oncology FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Intera Oncology is registered with the FDA (registration 3015537318) in Newton, MA, United States. It lists 2 device types. The FDA files 2 510(k) clearances and 1 PMA approval under its listings, the newest dated March 16, 2022. 1 recall event names it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Intera Oncology

FDA registration number: 3015537318
Address: 180 Wells Avenue Suite 300A, Newton, MA, United States, 02459
Owner or operator: Boston Scientific Corporation (9912058)
Roles: Specification developer
First device listed: June 2, 2025
Registered through: 2026
Brand names listed: Intera 3000 Hepatic Artery Infusion Pump, Intera 3000 Hepatic Artery Infusion Pump Tapered Silicone Rubber Catheter (Radiopaque) with Connector

Devices it lists

Device	Product code	Class	Role	Source
Non-Coring (Huber) Needle	PTI	2	Specification developer	accessdata.fda.gov
Pump, Infusion, Implanted, Programmable	LKK	3	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 16, 2022	K213823	Intera Refill Kit	PTI	Substantially Equivalent	Intera Oncology, Inc.	accessdata.fda.gov
October 14, 2021	K211121	Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit	PTI	Substantially Equivalent	Intera Oncology, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
March 11, 1996	P890055	MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEM	LKK	86	March 16, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 10, 2022	90642	Class I	Terminated	INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.	Higher than expected flow rate.	accessdata.fda.gov

Compare with other makers

Updated March 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.