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510(k) K911142

LEAD TERMINAL PIN CAPS, VARIOUS MODELS by Biotronik, GmbH & Co. — Product Code DTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1991
Date Received
March 14, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pacemaker Lead Adaptor
Device Class
Class II
Regulation Number
870.3620
Review Panel
CV
Submission Type

Other clearances by Biotronik, GmbH & Co.

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  • K922742 — HPM 40 HEART PACEMAKER MONITOR (March 18, 1993)
  • K914109 — PIKOS 01 & PIKOS E 01 (February 26, 1992)
  • K910609 — PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP (August 28, 1991)
  • K910608 — PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP (July 30, 1991)
  • K905087 — TRIOS 02 (May 7, 1991)
  • K903928 — LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP (October 16, 1990)
  • K903929 — LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP (October 16, 1990)

Other clearances for product code DTD

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  • K041574 — CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 (July 12, 2004)
  • K031164 — PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV (June 19, 2003)
  • K024156 — PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING L (January 14, 2003)
  • K010787 — PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS (May 22, 2001)
  • K003454 — A1-CS-SB Y-ADAPTER, MODEL 124 871 (January 18, 2001)
  • K000210 — MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT (February 23, 2000)
  • K982220 — MODEL 2872 BIPOLAR LEAD ADAPTOR KIT (October 15, 1998)
  • K971930 — BK-N SEALING CAP (August 14, 1997)