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510(k) K001413

ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668 by Biotronik, Inc. — Product Code DTB

Clearance Details

Decision
ST ()
Decision Date
June 2, 2000
Date Received
May 4, 2000
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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  • K031274 — MODEL 5071 MYOCARDIAL PACING LEAD (May 22, 2003)
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  • K023205 — ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP (April 24, 2003)
  • K024053 — PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB (January 31, 2003)
  • 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)