Siemens-Pacesetter, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
7
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K942440AFP CARDIAC PACING SYSTEM MODEL 283August 8, 1994
K925038PACING LEAD MODEL 1188TJuly 15, 1994
K932892PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELSJuly 6, 1994
K930876SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146TJune 15, 1994
K925347MODEL 1148T TRANSVENOUS, SCREW-IN LEADJune 10, 1993
K920822CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODEJanuary 22, 1993
K921318ADAPTING SLEEVE KIT MODEL 4023August 3, 1992