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Pacesetter, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K972814LOCATOR MODEL 4036February 23, 1998
K960854SIEMENS SERVO ULTRA NEBULIZER 345December 23, 1996
K954714AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION)February 1, 1996
K954551DF-1 TERMINAL CAPDecember 26, 1995
K952206PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATINGAugust 31, 1995
K951950PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATINGAugust 31, 1995
K951087TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEADJune 29, 1995
K950140IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069April 6, 1995