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510(k) K870014

HCI GENERAL PURPOSE CATHETER STYLET by Health Care Innovations, Inc. — Product Code KGZ

K870014 is an FDA 510(k) premarket notification submitted by Health Care Innovations, Inc. for the device "HCI GENERAL PURPOSE CATHETER STYLET". The FDA issued a decision of Substantially Equivalent on February 6, 1987. The device falls under product code KGZ (Accessories, Catheter), a Class I device regulated under 21 CFR 878.4200. Health Care Innovations, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1987
Date Received
January 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Health Care Innovations, Inc.

  • K881452 — FOLDING WHEELCHAIR (April 21, 1988)
  • K872524 — SAFEWEIGH MAGIC SCALE (October 9, 1987)
  • K872940 — FOLDING WHEELCHAIR (August 4, 1987)
  • K870015 — HCI ALL PURPOSE DRAIN/CATHETER SET (February 6, 1987)

Other clearances for product code KGZ

  • K022306 — AART SILICONE TUBING (October 10, 2002)
  • K974295 — BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING (February 10, 1998)
  • K973183 — WOUND DRAINAGE HOLDER (January 23, 1998)
  • K955433 — DURALASTIC SILICONE TUBING (January 26, 1996)
  • K942315 — NAVARRE PERCUTANEOUS ACCESS SET (July 8, 1994)
  • K896087 — PALESTRANT IRRIGATION AND DRAINAGE SET (November 3, 1989)
  • K895041 — OPTICAL CATHETER(TM) INTRODUCER SETS (October 16, 1989)
  • K893406 — DESERET PRN ADAPTER (June 22, 1989)
  • K873009 — CONCEPT SWITCHING STICK (August 17, 1987)
  • K864115 — TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SU (November 7, 1986)

FDA data resources