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510(k) K873563

APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY by Aplicare, Inc. — Product Code JOL

K873563 is an FDA 510(k) premarket notification submitted by Aplicare, Inc. for the device "APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY". The FDA issued a decision of Substantially Equivalent on November 23, 1987. The device falls under product code JOL (Catheter And Tip, Suction), a Class II device regulated under 21 CFR 880.6740. Aplicare, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1987
Date Received
September 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter And Tip, Suction
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Aplicare, Inc.

  • K923299 — APLICARE ONE COMPUND BENZION TINCTURE SWABSTICK (January 18, 1994)
  • K895039 — STERILE SALINE - FOR SUCTION CATHETER LUBRICATION (October 3, 1989)
  • K861557 — APLICARE SKIN PROTECTANT PREP PAD (July 11, 1986)
  • K861558 — APLICARE SKIN PROTECTANT SWABSTICK (June 4, 1986)
  • K833185 — ACETONE ALCOHOL PREP PAD (October 31, 1983)
  • K833183 — APLICARE ONE ACETONE ALCOHOL SWABSTICK (October 31, 1983)
  • K833184 — APLICARE THREE ALCOHOL SWABSTICKS (October 27, 1983)
  • K833182 — APLICARE ALCOHOL PREP PAD (October 27, 1983)

Other clearances for product code JOL

  • K051370 — STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F (August 12, 2005)
  • K000265 — PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION (July 12, 2001)
  • K000266 — PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION (July 12, 2001)
  • K003402 — WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FO (May 1, 2001)
  • K994321 — STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP (October 25, 2000)
  • K974758 — HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE (March 9, 1998)
  • K974759 — HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE (March 9, 1998)
  • K974397 — STERILE SALINE FOR CATHETER CARE (February 10, 1998)
  • K973734 — STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION (February 5, 1998)
  • K972372 — GERM TRAPPER SUCTION TUBE HOLDER (December 11, 1997)

FDA data resources