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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 the device name listed in this FDA 510(k) record. The listed applicant is Access Scientific, LLC. It received FDA 510(k) clearance on 2018-09-18 under 510(k) 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. The listed applicant is Access Scientific, LLC. The 510(k) number is K182243.

When did The CVC WAND Safety Introducer with Valved Peelable Sheath receive FDA 510(k) clearance?

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

Who is the listed applicant for The CVC WAND Safety Introducer with Valved Peelable Sheath?

The FDA 510(k) record lists Access Scientific, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Access Scientific, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183066The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr ModelK181563The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD TechnologyK162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model

Related Devices (Code: DYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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