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510(k) K851088

UMI ANGIOGRAPHIC CATHETER by Universal Medical Instrument Corp. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1985
Date Received
March 18, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

Other clearances by Universal Medical Instrument Corp.

  • K962180 — CATH SEAL (November 7, 1996)
  • K935077 — CATH-SEAL (June 7, 1994)
  • K897128 — UMI BRAIDED CATHETER CONNECTOR (March 1, 1990)
  • K881796 — UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE (July 26, 1988)
  • K863178 — UMI STEERABLE TORQUE GUIDE WIRE (September 19, 1986)
  • K861984 — UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO (August 5, 1986)
  • K860168 — UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE (February 19, 1986)
  • K850820 — PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID (April 10, 1985)
  • K844558 — UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE (January 31, 1985)
  • K842259 — PCI W/CATH-SEAL SIDE FLOW FITTING (August 1, 1984)

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