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510(k) K813518

IMPLANT AID SPLICING CRIMP & SLEEVE by Intermedics, Inc. — Product Code KFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1982
Date Received
December 16, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Materials, Repair Or Replacement, Pacemaker
Device Class
Class III
Regulation Number
870.3710
Review Panel
CV
Submission Type

Other clearances by Intermedics, Inc.

  • K954610 — MODEL 430-07 ENDOCARDIAL PACING LEAD (December 16, 1996)
  • K955122 — INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL (November 4, 1996)
  • K962174 — BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07) (August 21, 1996)
  • K955550 — CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD (June 19, 1996)
  • K960281 — IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY (June 18, 1996)
  • K954719 — INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD (February 27, 1996)
  • K933278 — INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 (March 15, 1995)
  • K922042 — CARDIFIX ENDOCARDIAL PACING LEAD (April 29, 1993)
  • K922972 — MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD (January 22, 1993)
  • K920530 — INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG (March 17, 1992)

Other clearances for product code KFJ

  • K913919 — UNIVERSAL TERMINAL CAP, 3.2MM (December 31, 1991)
  • K852236 — MEDTRONIC MODEL 5867-1A (July 11, 1985)