Atlas FDA

CARDIAC ELECTRODE

FDA 510(k) clearance K760443 · decided 1976-08-26

Clearance details

K-number
K760443
Device name
CARDIAC ELECTRODE
Applicant
Meadox Medicals, Div. Boston Scientific Corp.
Decision
Substantially Equivalent
Date received
1976-08-16
Decision date
1976-08-26
Days to decision
10 days
Clearance type
Traditional
Product code
DTB
Device class
3
Regulation number
870.3680
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP (K021217)Biotronik, Inc.2002-05-01
MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP (K010281)Biotronik, Inc.2002-04-09
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
STRKYER KNEE AUGMENTATION GRAFT (P850054)Meadox Medicals, Div. Boston Scientific Corp.1988-12-30