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510(k) K860168

UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE by Universal Medical Instrument Corp.

K860168 is an FDA 510(k) premarket notification submitted by Universal Medical Instrument Corp. for the device "UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE". The FDA issued a decision of Substantially Equivalent on February 19, 1986. Universal Medical Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1986
Date Received
January 17, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • 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)
  • K842259 — PCI W/CATH-SEAL SIDE FLOW FITTING (August 1, 1984)

FDA data resources