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FDA 510(k)

ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903

K-Number: K940079 · 1994-11-30

ApplicantArrow Intl., Inc.
Decision Date1994-11-30
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903 is the device name listed in this FDA 510(k) record. The listed applicant is Arrow Intl., Inc.. It received FDA 510(k) clearance on 1994-11-30 under 510(k) number K940079. 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 ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903?

ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903 is a medical device that received FDA 510(k) clearance on 1994-11-30. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K940079.

When did ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903 receive FDA 510(k) clearance?

ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903 received FDA 510(k) clearance on 1994-11-30, under 510(k) number K940079.

Who is the listed applicant for ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903?

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

What is the FDA product code for ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903?

The FDA product code for ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903 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.

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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