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510(k) K790468

IMPLANTABLE HEART LEAD EXTENDER by Arco Medical Products Co. — Product Code DTD

K790468 is an FDA 510(k) premarket notification submitted by Arco Medical Products Co. for the device "IMPLANTABLE HEART LEAD EXTENDER". The FDA issued a decision of Substantially Equivalent on March 19, 1979. The device falls under product code DTD (Pacemaker Lead Adaptor), a Class II device regulated under 21 CFR 870.3620. Arco Medical Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1979
Date Received
March 5, 1979
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 Arco Medical Products Co.

  • K802588 — MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN. (November 19, 1980)
  • K801806 — EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE (September 9, 1980)
  • K800837 — PROGRAMMABLE BIPOLAR CARDIAC GENERATOR (June 30, 1980)
  • K801241 — UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN. (June 30, 1980)
  • K800838 — ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN. (June 4, 1980)
  • K800326 — ARCOLITH 3021-CARDIAC PULSE GENERATOR (March 17, 1980)
  • K792299 — ARCOLITH 3020-CARDIAC PULSE GENERATOR (November 29, 1979)
  • K792216 — ARCOLITH 2100-CARDIAC PULSE GENERATOR (November 29, 1979)
  • K791715 — ARCOLITH 2000 (September 27, 1979)
  • K791147 — ARCO PROGAMMABLE PACEMAKER SYSTEM (August 3, 1979)

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