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510(k) K891905

CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE by Pacesetter Systems — Product Code DTB

K891905 is an FDA 510(k) premarket notification submitted by Pacesetter Systems for the device "CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE". The FDA issued a decision of Substantially Equivalent on June 5, 1989. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Pacesetter Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1989
Date Received
March 27, 1989
Clearance Type
Traditional
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

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)
  • K900512 — SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS (June 25, 1990)
  • K900550 — FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T (April 20, 1990)
  • K895447 — ENDOCARDIAL SCREW-IN LEAD MODEL 1020T (December 20, 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)

Other clearances for product code DTB

  • K061212 — BIOTRONIK ENDOCARDIAL PACING LEADS (July 10, 2006)
  • K041809 — PERMANENT PACING LEAD, MODEL PY2 (August 6, 2004)
  • K040569 — PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU (April 7, 2004)
  • K031274 — MODEL 5071 MYOCARDIAL PACING LEAD (May 22, 2003)
  • K031210 — MODEL 4951M MYOCARDIAL UNIPOLAR LEAD (May 16, 2003)
  • 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)

FDA data resources