Home / 510(k) Clearances / K951098

510(k) K951098

HDC VADD (VASCULAR ACCESS DEVICE) TUNNELER by Hdc Corp. — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1995
Date Received
March 9, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type

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  • 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)
  • K033853 — MODIFICATION TO V-CATH POLY PICC (January 14, 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)

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  • K241910 — Neonav ECG Tip Location System (January 19, 2025)
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