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510(k) K923621

EXTERNAL DEMAND PACEMAKER by Oscor Medical Corp. — Product Code DTE

K923621 is an FDA 510(k) premarket notification submitted by Oscor Medical Corp. for the device "EXTERNAL DEMAND PACEMAKER". The FDA issued a decision of Substantially Equivalent on May 19, 1993. The device falls under product code DTE (Pulse-Generator, Pacemaker, External), a Class II device regulated under 21 CFR 870.3600. Oscor Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1993
Date Received
July 21, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pulse-Generator, Pacemaker, External
Device Class
Class II
Regulation Number
870.3600
Review Panel
CV
Submission Type

Other clearances by Oscor Medical Corp.

  • K964107 — OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR (April 1, 1997)
  • K925168 — MISCELLANEOUS PACING LEAD (May 3, 1994)
  • K912867 — OSCOR MEDICAL CORP PERMANENT PACING LEAD (February 4, 1992)
  • K915007 — PERMANENT PACING LEADS, MODIFICATION (January 27, 1992)
  • K915008 — PERMANENT PACING PAD, MODIFICATION (January 27, 1992)
  • K913158 — MODIFIED OSCOR PY PACING LEADS/MODIFICATION (September 23, 1991)
  • K913204 — MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION (September 23, 1991)
  • K913393 — IMPLANT PACING LEAD, RETRACTABLE, MODIFICATION (September 23, 1991)
  • K913201 — PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION (September 23, 1991)
  • K913205 — OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF (September 23, 1991)

Other clearances for product code DTE

  • K241781 — Solo Pace Control (January 10, 2025)
  • K232721 — Lifetech Cardio Temporary Pacemaker (January 7, 2024)
  • K201011 — Medtronic Model 5392 External Pulse Generator (EPG) (May 13, 2020)
  • K190825 — Medtronic Model 5392 External Pulse Generator (EPG) (April 30, 2019)
  • K182839 — Lifetech Cardio Model 8301 Temporary Pacemaker (February 28, 2019)
  • K181973 — Medtronic Model 5392 External Pulse Generator (EPG) (August 21, 2018)
  • K180873 — Medtronic Model 53401 External Pulse Generator (EPG) (April 19, 2018)
  • K162054 — Medtronic Temporary External Pacemaker 53401 (October 18, 2016)
  • K162550 — Medtronic Model 5392 External Pulse Generator (EPG) (October 12, 2016)
  • K150246 — Medtronic Model 5392 External Pulse Generator (EPG) (February 18, 2015)

FDA data resources