B. Braun Interventional Systems

FDA Regulatory Profile

B. Braun Interventional Systems appears in FDA public data with 1 recall, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2382-2015, Class II) was initiated on June 16, 2015. Its most recent 510(k) clearance was granted on June 12, 2017.

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2382-2015Class IICelsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (CJune 16, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K162625SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon CathetersJune 12, 2017
K152765VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEMFebruary 26, 2016
K130576CELSITE IMPLANTABLE ACCESS PORT SYSTEMSApril 2, 2013