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FDA 510(k)

The CVC WAND Safety Introducer with Valved Peelable Sheath

K-Number: K182243 · 2018-09-18

ApplicantAccess Scientific, LLC
Decision Date2018-09-18
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

The CVC WAND Safety Introducer with Valved Peelable Sheath is a medical device manufactured by Access Scientific, LLC. It received FDA 510(k) clearance on 2018-09-18 under approval number K182243. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The CVC WAND Safety Introducer with Valved Peelable Sheath?

The CVC WAND Safety Introducer with Valved Peelable Sheath is a medical device that received FDA 510(k) clearance on 2018-09-18. It is manufactured by Access Scientific, LLC. The 510(k) number is K182243.

When was The CVC WAND Safety Introducer with Valved Peelable Sheath approved by the FDA?

The CVC WAND Safety Introducer with Valved Peelable Sheath received FDA 510(k) clearance on 2018-09-18, under approval number K182243.

What company makes The CVC WAND Safety Introducer with Valved Peelable Sheath?

The CVC WAND Safety Introducer with Valved Peelable Sheath is manufactured by Access Scientific, LLC.

What is the FDA product code for The CVC WAND Safety Introducer with Valved Peelable Sheath?

The FDA product code for The CVC WAND Safety Introducer with Valved Peelable Sheath is DYB.

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Other Devices by Access Scientific, LLC

K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model K181563The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology K183066The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model

Related Devices (Code: DYB)

K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelAccess Scientific, LLC K162097InTRAkitMedtronic Vascular K162769Pinpoint GT Introducer NeedleC.R. Bard, Inc. K153771TXM Guiding SheathTexasmedical Technologies, Inc. K162184Edwards eSheath Introducer SetEdward Lifesciences K153494HQS Introducer (Model 2064-HQS)Alseal

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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