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510(k) K832916

INIVOX ELECTRODE/CATHETER SYS by Critikon Company, LLC — Product Code LLE

K832916 is an FDA 510(k) premarket notification submitted by Critikon Company, LLC for the device "INIVOX ELECTRODE/CATHETER SYS". The FDA issued a decision of Substantially Equivalent on November 14, 1983. The device falls under product code LLE (Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease), a Class III device. Critikon Company, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1983
Date Received
August 29, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease
Device Class
Class III
Regulation Number
Review Panel
NE
Submission Type

Other clearances by Critikon Company, LLC

  • K002248 — DINAMAP PRO 1000 MONITOR, MODEL 1000 (September 21, 2000)
  • K000500 — DINAMAP ADVANCED NIBP MODULE (May 26, 2000)
  • K992638 — DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400 (February 24, 2000)
  • K982342 — DINAMAP MPS SELECT PORTABLE MONITOR (August 14, 1998)
  • K943709 — DINAMAP PLUS VITAL SIGNS MONOITOR (June 16, 1995)
  • K942700 — DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340 (March 1, 1995)
  • K933404 — CRITIKON CENTRAL STATIN MONITOR (February 9, 1994)
  • K933050 — CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH (December 14, 1993)
  • K915697 — CRITIKON VITAL SIGNS MODULE (July 1, 1993)
  • K921295 — INTRAVENOUS CATHETERS MODIFICATIONS (May 17, 1993)

Other clearances for product code LLE

  • K833430 — BLOOD GAS EXPERSYSTEM 8700 (February 10, 1984)

FDA data resources