Home / 510(k) Clearances / K902889

510(k) K902889

A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE. by Biotronik, GmbH & Co. — Product Code DTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1990
Date Received
July 2, 1990
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)
  • K911142 — LEAD TERMINAL PIN CAPS, VARIOUS MODELS (August 9, 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)

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  • 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)
  • K970388 — A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE (August 14, 1997)