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FDA 510(k)

NAMIC SELDINGER INTRODUCER NEEDLE

K-Number: K871378 · 1987-05-06

ApplicantNorth American Instrument Corp.
Decision Date1987-05-06
Product CodeDRC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NAMIC SELDINGER INTRODUCER NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is North American Instrument Corp.. It received FDA 510(k) clearance on 1987-05-06 under 510(k) number K871378. 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 NAMIC SELDINGER INTRODUCER NEEDLE?

NAMIC SELDINGER INTRODUCER NEEDLE is a medical device that received FDA 510(k) clearance on 1987-05-06. The listed applicant is North American Instrument Corp.. The 510(k) number is K871378.

When did NAMIC SELDINGER INTRODUCER NEEDLE receive FDA 510(k) clearance?

NAMIC SELDINGER INTRODUCER NEEDLE received FDA 510(k) clearance on 1987-05-06, under 510(k) number K871378.

Who is the listed applicant for NAMIC SELDINGER INTRODUCER NEEDLE?

The FDA 510(k) record lists North American Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NAMIC SELDINGER INTRODUCER NEEDLE?

The FDA product code for NAMIC SELDINGER INTRODUCER NEEDLE is DRC.

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Other records listing North American Instrument Corp. 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.

K960801SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS)K955554HEMO-VALVEK960310EPIC INTRODUCER SHEATHK922552MORSE(R) ANGIOGRAPHIC CATHETERSK915078MORSE HEMOSTATIC CATHETER INTRODUCER SETK905208MORSE ANESTHESIA

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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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