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510(k) K822586

TEFLON COATED GUIDE WIRES & CATHETER by Universal Medical Instrument Corp. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1982
Date Received
August 26, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
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)
  • K851088 — UMI ANGIOGRAPHIC CATHETER (May 16, 1985)
  • K850820 — PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID (April 10, 1985)
  • K844558 — UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE (January 31, 1985)

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