Home / 510(k) Clearances / K960216

510(k) K960216

CPR SUCTION CATHETER KIT by Custom Pack Reliability — Product Code JOL

K960216 is an FDA 510(k) premarket notification submitted by Custom Pack Reliability for the device "CPR SUCTION CATHETER KIT". The FDA issued a decision of Substantially Equivalent on April 15, 1996. The device falls under product code JOL (Catheter And Tip, Suction), a Class II device regulated under 21 CFR 880.6740. Custom Pack Reliability has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1996
Date Received
January 16, 1996
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 Custom Pack Reliability

  • K960205 — CPR TRACHEOTOMY CARE TRAY (August 27, 1996)
  • K960243 — CPR C-SECTION DELIVERY PACK (May 23, 1996)
  • K960239 — CPR D & C TRAY (May 23, 1996)
  • K960211 — CPR TOTAL KNEE PACK (April 12, 1996)
  • K960206 — CPR DRESSING CHANGE TRAY (April 12, 1996)
  • K960213 — CPR TOTAL HIP PACK (April 12, 1996)
  • K960210 — CPR ORTHO HAND PACK (April 12, 1996)
  • K960209 — CPR HEART PACK (April 4, 1996)
  • K960215 — CPR URETHRAL CATHETER TRAY (April 1, 1996)
  • K960212 — CPR IRRIGATION TRAY (April 1, 1996)

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)
  • K974759 — HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE (March 9, 1998)
  • K974758 — HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 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