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510(k) K042105

Device
CLIPPER DIAGNOSTIC ELECTRODE CATHETER
Applicant
Bard Electrophysiology
510(k) number
K042105
Product code
DRF
Decision
Substantially Equivalent (SESE)
Decision date
2004-09-23
Date received
2004-08-04
Regulation
870.1220
Classification name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
DEBORAH L HERRINGTON
Address
55 Technology Dr. Lowell MA US 01851 01851

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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