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510(k) K894718

ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33 by Intermedics, Inc. — Product Code DTD

K894718 is an FDA 510(k) premarket notification submitted by Intermedics, Inc. for the device "ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33". The FDA issued a decision of Substantially Equivalent on September 5, 1989. The device falls under product code DTD (Pacemaker Lead Adaptor), a Class II device regulated under 21 CFR 870.3620. Intermedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1989
Date Received
July 25, 1989
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 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 DTD

  • K143463 — IS4/DF4 Port Plug (March 19, 2015)
  • K132008 — 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866- (July 30, 2013)
  • 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)

FDA data resources