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FDA 510(k)

DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION

K-Number: K914985 · 1991-12-20

ApplicantE-Z-Em, Inc.
Decision Date1991-12-20
Product CodeDRC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is E-Z-Em, Inc.. It received FDA 510(k) clearance on 1991-12-20 under 510(k) number K914985. 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 DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION?

DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-12-20. The listed applicant is E-Z-Em, Inc.. The 510(k) number is K914985.

When did DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION receive FDA 510(k) clearance?

DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION received FDA 510(k) clearance on 1991-12-20, under 510(k) number K914985.

Who is the listed applicant for DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION?

The FDA 510(k) record lists E-Z-Em, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION?

The FDA product code for DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION is DRC.

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Other records listing E-Z-Em, 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.

K071378MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIESK062449EMPOWERMR INJECTOR SYSTEM, MODEL 9730K063029EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900K053008E-Z-EM ENDOSCOPIC CO2 REGULATORK041178EMPOWER TRANSFER SET, (CAT. NO. 7725)K031571EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825

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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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