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510(k) K022752

PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15 by Hdc Corp. — Product Code CAZ

K022752 is an FDA 510(k) premarket notification submitted by Hdc Corp. for the device "PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15". The FDA issued a decision of Substantially Equivalent on September 9, 2003. The device falls under product code CAZ (Anesthesia Conduction Kit), a Class II device regulated under 21 CFR 868.5140. Hdc Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2003
Date Received
August 19, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anesthesia Conduction Kit
Device Class
Class II
Regulation Number
868.5140
Review Panel
AN
Submission Type

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

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)
  • K033853 — MODIFICATION TO V-CATH POLY PICC (January 14, 2004)
  • K032404 — SELDINGER SAFETY NEEDLE INTRODUCER (September 10, 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)

Other clearances for product code CAZ

  • K222341 — Arrow 0.2 Micron Flat Filter, GVS (February 13, 2023)
  • K210983 — BD Epilor Syringe (May 19, 2022)
  • K201356 — Plastic LOR Syringe (February 12, 2021)
  • K202699 — E-Cath STIM acc. Tsui (December 29, 2020)
  • K190345 — VPC (May 16, 2019)
  • K161075 — Arrow Epidural Catheter Kit (October 4, 2016)
  • K153652 — ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set (June 21, 2016)
  • K143581 — Arrow Epidural Catheter Kit (June 26, 2015)
  • K122690 — ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE (December 21, 2012)
  • K110053 — CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRIN (September 14, 2012)

FDA data resources