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510(k) K871422

OLYMPUS ANGIOSCOPY PUMP by Olympus Corp. — Product Code DQI

K871422 is an FDA 510(k) premarket notification submitted by Olympus Corp. for the device "OLYMPUS ANGIOSCOPY PUMP". The FDA issued a decision of Substantially Equivalent on August 12, 1987. The device falls under product code DQI (Withdrawal/Infusion Pump), a Class II device regulated under 21 CFR 870.1800. Olympus Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1987
Date Received
April 9, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Withdrawal/Infusion Pump
Device Class
Class II
Regulation Number
870.1800
Review Panel
HO
Submission Type

Other clearances by Olympus Corp.

  • K915402 — EW-10 AND EW-20 (June 23, 1995)
  • K933200 — OLYMPUS PBD STENTS (April 5, 1995)
  • K942338 — OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES (November 30, 1994)
  • K931763 — HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS (August 29, 1994)
  • K934835 — FLOVAL (June 21, 1994)
  • K931764 — HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES (June 8, 1994)
  • K915857 — FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE (March 11, 1994)
  • K931994 — RESECTOSCOPE SHEATH (February 17, 1994)
  • K934889 — OLYMPUS IMAGEMANAGER SYSTEM (January 28, 1994)
  • K934888 — OLYMPUS IMAGEMANAGERSYSTEM (January 25, 1994)

Other clearances for product code DQI

  • K960486 — KSEA MODEL 383320 20 ANGIOMAT (October 25, 1996)
  • K935763 — SURGIPUMP (April 21, 1994)
  • K922541 — USCI SUPER 9 PTCA GUIDING CATHETER (December 8, 1992)
  • K924110 — LEOCOR CORFLO PUMP -- MODIFICATION (September 1, 1992)
  • K905189 — BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL) (January 30, 1991)
  • K902444 — CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP (August 30, 1990)
  • K895688 — NOBLES-LAI ENGINEERING INFUSION PUMP (February 26, 1990)
  • K895074 — ANGIOSCOPY PUMP (January 31, 1990)

FDA data resources