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510(k) K162322

the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model by Access Scientific, LLC — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2016
Date Received
August 19, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Access Scientific, LLC

  • K183066 — The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFl (July 25, 2019)
  • K181563 — The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C (September 26, 2018)
  • K182243 — The CVC WAND Safety Introducer with Valved Peelable Sheath (September 18, 2018)
  • K131148 — THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH (September 4, 2013)
  • K131300 — THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER (June 7, 2013)
  • K121748 — THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL (July 27, 2012)
  • K111417 — THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER (July 15, 2011)
  • K111138 — THE PICC WAND (R) PEELABLE SAFETY INTRODUCER (June 22, 2011)
  • K101422 — THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER (March 22, 2011)
  • K101150 — PICC WAND PEELABLE SAFETY INTRODUCER (August 13, 2010)

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  • K252309 — PerQseal Introducers (October 23, 2025)
  • K251838 — Introducer Sheath Set (October 21, 2025)
  • K252766 — 14Fr Low Profile Introducer Kit (October 8, 2025)
  • K252441 — Primero Safe Access System (September 29, 2025)
  • K252227 — Pounce(TM) Sheath (September 24, 2025)