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510(k) K800635

C.C.-PAK by Respiratory Care, Inc. — Product Code JOL

K800635 is an FDA 510(k) premarket notification submitted by Respiratory Care, Inc. for the device "C.C.-PAK". The FDA issued a decision of Substantially Equivalent on April 10, 1980. The device falls under product code JOL (Catheter And Tip, Suction), a Class II device regulated under 21 CFR 880.6740. Respiratory Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1980
Date Received
March 21, 1980
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 Respiratory Care, Inc.

  • K892230 — RCI VIRAL/BACTERIAL FILTER (August 28, 1989)
  • K884150 — MODIFIED CONCHATHERM III CONTROLLED HEATER (November 21, 1988)
  • K881625 — CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL (June 21, 1988)
  • K864147 — AQUAVALVE (December 5, 1986)
  • K863955 — COLBY LEVEL ALARM (November 7, 1986)
  • K861555 — CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT (June 5, 1986)
  • K834151 — CONCHATHERM LHF HUMIDIFIER HEATER (January 13, 1984)
  • K833974 — AQUAPAK 020 HUMIDIFIER ADAPTER (December 16, 1983)
  • K832453 — SLIMB SINGLE LIMB BREATHING CIRCUIT (October 27, 1983)
  • K811524 — AQUACADE (July 1, 1981)

Other clearances for product code JOL

  • K051370 — STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F (August 12, 2005)
  • K000266 — PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION (July 12, 2001)
  • K000265 — PRIMARY CARE SOLUTIONS STERILE WATER 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