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FDA 510(k)

ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET

K-Number: K970229 · 1998-02-13

ApplicantArrow Intl., Inc.
Decision Date1998-02-13
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET 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 1998-02-13 under 510(k) number K970229. 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 TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET?

ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET is a medical device that received FDA 510(k) clearance on 1998-02-13. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K970229.

When did ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET receive FDA 510(k) clearance?

ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET received FDA 510(k) clearance on 1998-02-13, under 510(k) number K970229.

Who is the listed applicant for ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET?

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 TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET?

The FDA product code for ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET is DYB.

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Other records listing Arrow Intl., Inc. as applicant

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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

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

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