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510(k) K870015

HCI ALL PURPOSE DRAIN/CATHETER SET by Health Care Innovations, Inc. — Product Code GBS

K870015 is an FDA 510(k) premarket notification submitted by Health Care Innovations, Inc. for the device "HCI ALL PURPOSE DRAIN/CATHETER SET". The FDA issued a decision of Substantially Equivalent on February 6, 1987. The device falls under product code GBS (Catheter, Ventricular, General & Plastic Surgery), 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
Catheter, Ventricular, General & Plastic Surgery
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)
  • K870014 — HCI GENERAL PURPOSE CATHETER STYLET (February 6, 1987)

Other clearances for product code GBS

  • K912645 — ATRIUMS PDR THORACIC CATHETER (September 13, 1991)
  • K883887 — AXIOM ATRAUM WOUND DRAINS (February 17, 1989)
  • K881873 — INTRODUCTION/DRAINAGE CATHETER & ACCESS (May 18, 1988)
  • K880895 — URESIL WOUND DRAIN TROCAR (March 14, 1988)
  • K880376 — NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP (February 16, 1988)
  • K873377 — CLOSED CHEST DRAINAGE SET W/SUTURES (October 28, 1987)
  • K872460 — AN3000 MAHONEY DRAIN (July 23, 1987)
  • K872457 — AN3500 WORTH DRAIN (July 21, 1987)
  • K872459 — AN3100 MULHOLLAND DRAIN (July 21, 1987)
  • K863560 — URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA (September 29, 1986)

FDA data resources