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510(k) K033853

MODIFICATION TO V-CATH POLY PICC by Hdc Corp. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2004
Date Received
December 11, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by Hdc Corp.

  • K091390 — HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2 (July 30, 2009)
  • K071875 — V-CATH POLY PICC (November 5, 2007)
  • K071851 — HDC STERILE SPIDER SCREW (October 18, 2007)
  • K052471 — HDC SPIDER SCREW (December 23, 2005)
  • K023342 — NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE (March 2, 2004)
  • K032404 — SELDINGER SAFETY NEEDLE INTRODUCER (September 10, 2003)
  • K022752 — PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-1 (September 9, 2003)
  • K022099 — SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390- (September 20, 2002)
  • K010425 — EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) (March 15, 2001)
  • K994059 — CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07 (October 13, 2000)

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