Atlas FDA

PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS

FDA 510(k) clearance K014209 · decided 2002-01-18

Clearance details

K-number
K014209
Device name
PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS
Applicant
Padpro, LLC
Decision
Substantially Equivalent
Date received
2001-12-21
Decision date
2002-01-18
Days to decision
28 days
Clearance type
Special
Product code
MKJ
Device class
3
Regulation number
870.5310
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Deer Field, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO PHIL recall (Z-0454-2015)ConMed Corporation2014-12-04
ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPARABLE TO PH recall (Z-0455-2015)ConMed Corporation2014-12-04
ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO P recall (Z-0456-2015)ConMed Corporation2014-12-04
PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The Pa recall (Z-1317-2013)ConMed Corporation2013-05-13