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510(k) K101422

THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER by Access Scientific, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2011
Date Received
May 20, 2010
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, Inc.

  • 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)
  • K162322 — the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model (November 17, 2016)
  • 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)
  • K101150 — PICC WAND PEELABLE SAFETY INTRODUCER (August 13, 2010)

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  • K252766 — 14Fr Low Profile Introducer Kit (October 8, 2025)
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  • K252227 — Pounce(TM) Sheath (September 24, 2025)