Home / 510(k) Clearances / K915078

510(k) K915078

MORSE HEMOSTATIC CATHETER INTRODUCER SET by North American Instrument Corp. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1992
Date Received
November 8, 1991
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 North American Instrument Corp.

  • K960801 — SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS) (March 29, 1996)
  • K955554 — HEMO-VALVE (March 4, 1996)
  • K960310 — EPIC INTRODUCER SHEATH (February 7, 1996)
  • K922552 — MORSE(R) ANGIOGRAPHIC CATHETERS (March 3, 1993)
  • K905208 — MORSE ANESTHESIA (January 10, 1992)
  • K912961 — MORSE VASCULAR INTRODUCER SET (September 11, 1991)
  • K910764 — THE PERCEPTOR(TM) STAND ALONE TRANSDUCER (April 22, 1991)
  • K903493 — NAMIC CONTRAST SAVINGS DELIVERY SYSTEM (March 26, 1991)
  • K904275 — MORSE BALLOON INFLATION DEVICE (January 3, 1991)
  • K903606 — GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER (September 27, 1990)

Other clearances for product code DYB

  • K260163 — AuST CSP Introducer (February 19, 2026)
  • K254236 — Peel-Away Introducer Sheath (February 9, 2026)
  • K253652 — Genie MAX Large Bore Introducer Sheath (January 22, 2026)
  • K252508 — Intri26 Introducer Sheath (December 17, 2025)
  • K253741 — V•Stick™ Vascular Access Set (December 15, 2025)
  • K252309 — PerQseal Introducers (October 23, 2025)
  • K251838 — Introducer Sheath Set (October 21, 2025)
  • K252766 — 14Fr Low Profile Introducer Kit (October 8, 2025)
  • K252441 — Primero Safe Access System (September 29, 2025)
  • K252227 — Pounce(TM) Sheath (September 24, 2025)