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510(k) K032127

HEMEDEX FIXATION DEVICE by Hemedex Incorporated — Product Code KNY

K032127 is an FDA 510(k) premarket notification submitted by Hemedex Incorporated for the device "HEMEDEX FIXATION DEVICE". The FDA issued a decision of Substantially Equivalent on December 30, 2003. The device falls under product code KNY (Accessories, Catheter, G-U), a Class II device regulated under 21 CFR 876.5130. Hemedex Incorporated has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2003
Date Received
July 10, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter, G-U
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Hemedex Incorporated

  • K141869 — QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT (October 10, 2014)
  • K032337 — HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 (October 21, 2003)
  • K013376 — QFLOW 500 PERFUSION MONITORING SYSTEM (May 8, 2002)

Other clearances for product code KNY

  • K182144 — Bi-Flex Evo (September 7, 2018)
  • K162356 — Vesair Cystoscopic Sheath (March 2, 2017)
  • K140441 — BI-FLEX URETERAL ACCESS SHEATH (June 17, 2014)
  • K140562 — WIJAY EZ-VOID EXTERNAL CATHETER VALVE (June 16, 2014)
  • K141252 — GUARDIAN URETHRAL SHEATH (June 9, 2014)
  • K131803 — GUARDIAN URETHRAL SHEATH (August 20, 2013)
  • K123170 — VARI-PASS VARIABLE LENGTH ACCESS SHEATH (February 4, 2013)
  • K120160 — ROCAMED ROCAUS PLATINUM (May 14, 2012)
  • K112209 — PREFILLED CATHETER INFLATION SYRINGE (September 8, 2011)
  • K090121 — PRE-FILLED CATHETER INFLATION SYRINGE (April 15, 2009)

FDA data resources