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510(k) K905300

PERMANENT PACING LEAD by Oscor Medical Corp. — Product Code DTB

K905300 is an FDA 510(k) premarket notification submitted by Oscor Medical Corp. for the device "PERMANENT PACING LEAD". The FDA issued a decision of Substantially Equivalent on May 7, 1991. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Oscor Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1991
Date Received
November 27, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Permanent Pacemaker Electrode
Device Class
Class III
Regulation Number
870.3680
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)
  • 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)

Other clearances for product code DTB

  • K061212 — BIOTRONIK ENDOCARDIAL PACING LEADS (July 10, 2006)
  • K041809 — PERMANENT PACING LEAD, MODEL PY2 (August 6, 2004)
  • K040569 — PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU (April 7, 2004)
  • K031274 — MODEL 5071 MYOCARDIAL PACING LEAD (May 22, 2003)
  • K031210 — MODEL 4951M MYOCARDIAL UNIPOLAR LEAD (May 16, 2003)
  • K023205 — ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP (April 24, 2003)
  • K024053 — PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB (January 31, 2003)
  • K023803 — MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS (December 11, 2002)
  • K023099 — AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP (October 18, 2002)
  • K021217 — AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP (May 1, 2002)

FDA data resources