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510(k) K953750

Device
Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant
BOSTON SCIENTIFIC CORP.
510(k) number
K953750
Product code
DRF
Decision
Substantially Equivalent (SESE)
Decision date
1996-03-11
Date received
1995-08-10
Regulation
870.1220
Classification name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
WANDA M CARPINELLA
Address
One Boston Scientific Pl. Natick, MA US 01760 01760

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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