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FDA 510(k)

DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES

K-Number: K900664 · 1990-07-18

ApplicantSterimed, Inc.
Decision Date1990-07-18
Product CodeDRC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Sterimed, Inc.. It received FDA 510(k) clearance on 1990-07-18 under 510(k) number K900664. 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 COURNAND, SELDINGER & ONE-WALL NEEDLES?

DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES is a medical device that received FDA 510(k) clearance on 1990-07-18. The listed applicant is Sterimed, Inc.. The 510(k) number is K900664.

When did DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES receive FDA 510(k) clearance?

DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES received FDA 510(k) clearance on 1990-07-18, under 510(k) number K900664.

Who is the listed applicant for DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES?

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

What is the FDA product code for DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES?

The FDA product code for DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES is DRC.

Related Clinical Trials

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Other records listing Sterimed, 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.

K863512DRAPE STERICOVERK853044STERICOVER

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

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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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