Intera Oncology, Inc.

FDA Regulatory Profile

Intera Oncology, Inc. appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 2 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1522-2022, Class I) was initiated on July 10, 2022. Its most recent 510(k) clearance was granted on March 16, 2022.

Summary

Total Recalls
1 (1 Class I)
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1522-2022Class IINTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.July 10, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K213823Intera Refill KitMarch 16, 2022
K211121Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR PreOctober 14, 2021