Nucryo Vascular Inc.

FDA Regulatory Profile

Nucryo Vascular Inc. appears in FDA public data with 1 recall, 0 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0507-2020, Class II) was initiated on October 11, 2019.

Summary

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

Recent Recalls

NumberClassProductDate
Z-0507-2020Class IIThe PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliaOctober 11, 2019