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FDA 510(k)

THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006

K-Number: K081697 · 2008-12-04

ApplicantAccess Scientific, Inc.
Decision Date2008-12-04
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006 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 2008-12-04 under 510(k) number K081697. 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 WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006?

THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006 is a medical device that received FDA 510(k) clearance on 2008-12-04. The listed applicant is Access Scientific, Inc.. The 510(k) number is K081697.

When did THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006 receive FDA 510(k) clearance?

THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006 received FDA 510(k) clearance on 2008-12-04, under 510(k) number K081697.

Who is the listed applicant for THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006?

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 WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006?

The FDA product code for THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006 is DYB.

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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.

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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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