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510(k) K890277

HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT by Oscor Medical Corp. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1989
Date Received
January 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Oscor Medical Corp.

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  • 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)
  • K913201 — PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION (September 23, 1991)
  • K913202 — IMPLANT PACING LEAD, TINED #3262, MODIFICATION (September 23, 1991)
  • K913203 — IMPLANT PACING LEAD TINED #3390, MODIFICATION (September 23, 1991)
  • K913204 — MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION (September 23, 1991)

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