FDA 510(k)

GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE

K-Number: K951448 · 1996-03-27

Decision Date1996-03-27

Product CodeDRC

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Global Medical Products, Ltd.. It received FDA 510(k) clearance on 1996-03-27 under 510(k) number K951448. 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 GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE?

GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE is a medical device that received FDA 510(k) clearance on 1996-03-27. The listed applicant is Global Medical Products, Ltd.. The 510(k) number is K951448.

When did GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE receive FDA 510(k) clearance?

GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE received FDA 510(k) clearance on 1996-03-27, under 510(k) number K951448.

Who is the listed applicant for GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE?

The FDA 510(k) record lists Global Medical Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE?

The FDA product code for GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE is DRC.

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Other records listing Global Medical Products, Ltd. as applicant

K962821EPIDURAL ANESTHESIA KIT AND COMBINED SPINAL EPIDURAL ANESTHESIA KIT K961444GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725)K951421GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES K950311GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE

Related Devices (Code: DRC)

K240246Accusafe Transseptal Guidewire (GTR31180, GTR31230)Synaptic Medical Corporation K241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)Pressure Products Medical Device Manufacturing, LLC K221707SafeSept® Transseptal Guidewire (SS-140)Pressure Products Medical Device Manufacturing, LLC K212625PathBuilder Transseptal NeedleShanghai Microport EP Medtech Co., Ltd.K210328SafeSept Blunt NeedlePressure Products Medical Device Manufacturing, LLC K172950TSN 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.