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510(k) K925168

MISCELLANEOUS PACING LEAD by Oscor Medical Corp. — Product Code DTD

K925168 is an FDA 510(k) premarket notification submitted by Oscor Medical Corp. for the device "MISCELLANEOUS PACING LEAD". The FDA issued a decision of Substantially Equivalent on May 3, 1994. The device falls under product code DTD (Pacemaker Lead Adaptor), a Class II device regulated under 21 CFR 870.3620. Oscor Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1994
Date Received
October 13, 1992
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 Oscor Medical Corp.

  • K964107 — OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR (April 1, 1997)
  • K923621 — EXTERNAL DEMAND PACEMAKER (May 19, 1993)
  • K912867 — OSCOR MEDICAL CORP PERMANENT PACING LEAD (February 4, 1992)
  • K915008 — PERMANENT PACING PAD, MODIFICATION (January 27, 1992)
  • K915007 — PERMANENT PACING LEADS, MODIFICATION (January 27, 1992)
  • K913158 — MODIFIED OSCOR PY PACING LEADS/MODIFICATION (September 23, 1991)
  • K913205 — OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF (September 23, 1991)
  • K913204 — MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION (September 23, 1991)
  • K913201 — PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION (September 23, 1991)
  • K913393 — IMPLANT PACING LEAD, RETRACTABLE, MODIFICATION (September 23, 1991)

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