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510(k) K862872

FLEXIBLE VISUALIZATION CATHETER by American Edwards Laboratories — Product Code FEI

K862872 is an FDA 510(k) premarket notification submitted by American Edwards Laboratories for the device "FLEXIBLE VISUALIZATION CATHETER". The FDA issued a decision of Substantially Equivalent on October 24, 1986. The device falls under product code FEI (Instrument, Special Lens, For Endoscope), a Class I device regulated under 21 CFR 876.1500. American Edwards Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1986
Date Received
July 30, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Special Lens, For Endoscope
Device Class
Class I
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by American Edwards Laboratories

  • K873485 — EDSLAB (R) OCCLUSION BALLOON CATHETER (December 3, 1987)
  • K872596 — TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30 (September 30, 1987)
  • K872529 — THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2 (September 15, 1987)
  • K870444 — HOMEPRO II VOLUMETRIC INFUSION PUMP (April 17, 1987)
  • K864997 — MEDTRAC VP VOLUMETRIC INFUSION PUMP (February 27, 1987)
  • K864330 — SHEAR FORCE GAUGE (January 6, 1987)
  • K862724 — VEIN VALVE CUTTER (January 2, 1987)
  • K863596 — CHIN-FOGARTY INFLATION DEVICE (November 20, 1986)
  • K864155 — MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS (November 20, 1986)
  • K863986 — XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES (October 31, 1986)

Other clearances for product code FEI

  • K873795 — M-LENS (THIRTY DEGREE ENDOSCOPE) (January 14, 1988)

FDA data resources