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FDA 510(k)

ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE

K-Number: K924338 · 1993-03-18

ApplicantArrow Intl., Inc.
Decision Date1993-03-18
Product CodeDRC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE 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 1993-03-18 under 510(k) number K924338. The device is classified under product code DRC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE?

ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE is a medical device that received FDA 510(k) clearance on 1993-03-18. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K924338.

When did ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE receive FDA 510(k) clearance?

ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE received FDA 510(k) clearance on 1993-03-18, under 510(k) number K924338.

Who is the listed applicant for ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE?

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-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE?

The FDA product code for ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE is DRC.

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Other records listing Arrow Intl., Inc. as applicant

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Related Devices (Code: DRC)

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.

K240246Accusafe Transseptal Guidewire (GTR31180, GTR31230)Synaptic Medical CorporationK241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)Pressure Products Medical Device Manufacturing, LLCK221707SafeSept® Transseptal Guidewire (SS-140)Pressure Products Medical Device Manufacturing, LLCK212625PathBuilder Transseptal NeedleShanghai Microport EP Medtech Co., Ltd.K210328SafeSept Blunt NeedlePressure Products Medical Device Manufacturing, LLCK172950TSN Transseptal NeedlePressure Products Medical Device Manufacturing, 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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