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510(k) K900512

SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS by Pacesetter Systems — Product Code DTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1990
Date Received
February 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 Pacesetter Systems

  • K910924 — ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE (August 28, 1991)
  • K902147 — ENDOCARDIAL SCREW-IN LEAD MODEL 1028T (July 17, 1990)
  • K900550 — FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T (April 20, 1990)
  • K895447 — ENDOCARDIAL SCREW-IN LEAD MODEL 1020T (December 20, 1989)
  • K891905 — CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE (June 5, 1989)
  • K885267 — VS-1 MODEL NUMBER 251K PULSE GENERATOR (March 28, 1989)
  • K890547 — SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS (March 22, 1989)
  • K884733 — AFP MODEL 262T PULSE GENERATOR (February 10, 1989)
  • K883087 — PROLOG MP 658M PULSE GENERATOR (September 14, 1988)
  • K874205 — ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T (February 2, 1988)

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  • K031164 — PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV (June 19, 2003)
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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)
  • K971930 — BK-N SEALING CAP (August 14, 1997)