Atlas FDA

PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS

FDA 510(k) clearance K010787 · decided 2001-05-22

Clearance details

K-number
K010787
Device name
PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS
Applicant
Oscor, Inc.
Decision
Substantially Equivalent
Date received
2001-03-15
Decision date
2001-05-22
Days to decision
68 days
Clearance type
Traditional
Product code
DTD
Device class
2
Regulation number
870.3620
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Palm Harbor, FL, US
Third-party review
No
Expedited review
No

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RecordFirmDate
IS4/DF4 Port Plug (K143463)Oscor, Inc.2015-03-19
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PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR (K024156)Oscor, Inc.2003-01-14
A1-CS-SB Y-ADAPTER, MODEL 124 871 (K003454)Biotronik, Inc.2001-01-18
MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT (K000210)Medtronic Vascular2000-02-23
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Recalls involving this device

RecordFirmDate
Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107, 03116, 03108, 03109, 05756, recall (Z-2333-2008)Oscor, Inc.2008-09-24