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510(k) K864115

TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SU by Cathaid, Inc. — Product Code KGZ

K864115 is an FDA 510(k) premarket notification submitted by Cathaid, Inc. for the device "TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SU". The FDA issued a decision of Substantially Equivalent on November 7, 1986. The device falls under product code KGZ (Accessories, Catheter), a Class I device regulated under 21 CFR 878.4200. Cathaid, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1986
Date Received
October 10, 1986
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 Cathaid, Inc.

  • K863958 — TUBEGRIPPER, UROLOGICAL CATHETER & ACCESSORY (November 4, 1986)
  • K863957 — TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR GU (October 24, 1986)

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)
  • K870014 — HCI GENERAL PURPOSE CATHETER STYLET (February 6, 1987)

FDA data resources