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510(k) K013339

PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS by Oscor, Inc. — Product Code DTB

Clearance Details

Decision
ST ()
Decision Date
November 8, 2001
Date Received
October 9, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Permanent Pacemaker Electrode
Device Class
Class III
Regulation Number
870.3680
Review Panel
CV
Submission Type

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Other clearances for product code DTB

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  • K031210 — MODEL 4951M MYOCARDIAL UNIPOLAR LEAD (May 16, 2003)
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  • K023803 — MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS (December 11, 2002)
  • K023099 — AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP (October 18, 2002)
  • K021217 — AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP (May 1, 2002)