Intera Oncology, Inc.

Code	Device name	Class	Specialty	Clearances	Most recent
PTI	Non-Coring (Huber) Needle	Class II	General Hospital	2	2022-03-16

Date	PMA #	Trade name	Type	Code	Device name	Specialty
2026-03-16	P890055-S093	MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEM	30-Day Notice	LKK	Pump, Infusion, Implanted, Programmable	Unknown
2026-02-26	P890055-S092	lntera 3000 Hepatic Artery Infusion Pump	Real-Time Process	LKK	Pump, Infusion, Implanted, Programmable	Unknown
2025-05-09	P890055-S089	Intera 3000 Hepatic Artery Infusion Pump	Special (Immediate Track)	LKK	Pump, Infusion, Implanted, Programmable	Unknown
2025-05-07	P890055-S090	Intera 3000 Hepatic Arterial Infusion Pump	30-Day Notice	LKK	Pump, Infusion, Implanted, Programmable	Unknown
2024-10-30	P890055-S088	MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEM	30-Day Notice	LKK	Pump, Infusion, Implanted, Programmable	Unknown
2024-09-03	P890055-S085	Intera 3000 Hepatic Artery Infusion Pump	Normal 180 Day Track No User Fee	LKK	Pump, Infusion, Implanted, Programmable	Unknown
2024-07-12	P890055-S087	Intera 3000 Hepatic Artery Infusion Pump	30-Day Notice	LKK	Pump, Infusion, Implanted, Programmable	Unknown
2024-06-28	P890055-S086	Intera 3000 Hepatic Artery Infusion Pump	30-Day Notice	LKK	Pump, Infusion, Implanted, Programmable	Unknown
2024-03-01	P890055-S084	Intera 3000 Hepatic Artery Infusion Pump	30-Day Notice	LKK	Pump, Infusion, Implanted, Programmable	Unknown
2022-10-28	P890055-S082	Intera 3000 Hepatic Artery Infusion Pump	Special (Immediate Track)	LKK	Pump, Infusion, Implanted, Programmable	Unknown
2022-09-29	P890055-S083	Intera 3000 Hepatic Artery Infusion Pump	30-Day Notice	LKK	Pump, Infusion, Implanted, Programmable	Unknown
2022-06-22	P890055-S081	Intera 3000 Hepatic Artery Infusion Pump	Special (Immediate Track)	LKK	Pump, Infusion, Implanted, Programmable	Unknown
2022-05-20	P890055-S080	Intera 3000 Hepatic Artery Infusion Pump	30-Day Notice	LKK	Pump, Infusion, Implanted, Programmable	Unknown
2022-01-27	P890055-S079	lntera 3000 Hepatic Artery Infusion Pump	30-Day Notice	LKK	Pump, Infusion, Implanted, Programmable	Unknown
2021-12-06	P890055-S078	Intera 3000 Hepatic Artery Infusion Pump	30-Day Notice	LKK	Pump, Infusion, Implanted, Programmable	Unknown
2021-06-22	P890055-S074	Intera Hepatic Artery Infusion Pump	Normal 180 Day Track No User Fee	LKK	Pump, Infusion, Implanted, Programmable	Unknown
2021-04-13	P890055-S077	Intera 3000 Hepatic Artery Infusion Pump accessories	30-Day Notice	LKK	Pump, Infusion, Implanted, Programmable	Unknown
2021-01-22	P890055-S075	Medstream Programmable Infusion Pump System	135 Review Track For 30-Day Notice	LKK	Pump, Infusion, Implanted, Programmable	Unknown
2020-12-16	P890055-S076	Codman OR Prep Kits	30-Day Notice	LKK	Pump, Infusion, Implanted, Programmable	Unknown
2020-02-07	P890055-S073	3000 Series Implantable Infusion Pump and the MedStream Programmable Infusion System and Accessories	Normal 180 Day Track No User Fee	LKK	Pump, Infusion, Implanted, Programmable	Unknown
2020-02-07	P800036-S041	INFUSAID Implantable Infusion Pump and Accessories	Normal 180 Day Track No User Fee	LKK	Pump, Infusion, Implanted, Programmable	Unknown

Date	Severity	Status	Recall #	Product	Code	Reason
2022-07-10	Class I	Terminated	Z-1522-2022	INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.	—	Higher than expected flow rate.

Date	K-number	Device	Code	Class	Specialty
2022-03-16	K213823	Intera Refill Kit	PTI	Class II	General Hospital
2021-10-14	K211121	Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit	PTI	Class II	General Hospital

Clearance cadence by quarter

Product codes worked

PMA approvals (21)

Recalls (1)

All 510(k) clearances (2)