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FDA 510(k)

THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER

K-Number: K101422 · 2011-03-22

ApplicantAccess Scientific, Inc.
Decision Date2011-03-22
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Access Scientific, Inc.. It received FDA 510(k) clearance on 2011-03-22 under 510(k) number K101422. 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 POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER?

THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER is a medical device that received FDA 510(k) clearance on 2011-03-22. The listed applicant is Access Scientific, Inc.. The 510(k) number is K101422.

When did THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER receive FDA 510(k) clearance?

THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER received FDA 510(k) clearance on 2011-03-22, under 510(k) number K101422.

Who is the listed applicant for THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER?

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

What is the FDA product code for THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER?

The FDA product code for THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER is DYB.

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Other records listing Access Scientific, Inc. 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.

K121748THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELLK111417THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETERK111138THE PICC WAND (R) PEELABLE SAFETY INTRODUCERK101150PICC WAND PEELABLE SAFETY INTRODUCERK093022THE PICC WAND PEELABLE SAFETY INTRODUCERK090372THE WAND MICROACCESS SAFETY INTRODUCER

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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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