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FDA 510(k)

TRANSSEPTAL NEEDLE/TROCAR

K-Number: K011727 · 2002-05-02

ApplicantThomas Medical Products, Inc.
Decision Date2002-05-02
Product CodeDRC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRANSSEPTAL NEEDLE/TROCAR is the device name listed in this FDA 510(k) record. The listed applicant is Thomas Medical Products, Inc.. It received FDA 510(k) clearance on 2002-05-02 under 510(k) number K011727. 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 TRANSSEPTAL NEEDLE/TROCAR?

TRANSSEPTAL NEEDLE/TROCAR is a medical device that received FDA 510(k) clearance on 2002-05-02. The listed applicant is Thomas Medical Products, Inc.. The 510(k) number is K011727.

When did TRANSSEPTAL NEEDLE/TROCAR receive FDA 510(k) clearance?

TRANSSEPTAL NEEDLE/TROCAR received FDA 510(k) clearance on 2002-05-02, under 510(k) number K011727.

Who is the listed applicant for TRANSSEPTAL NEEDLE/TROCAR?

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

What is the FDA product code for TRANSSEPTAL NEEDLE/TROCAR?

The FDA product code for TRANSSEPTAL NEEDLE/TROCAR is DRC.

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Other records listing Thomas Medical Products, Inc. as applicant

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K122431HEARTSPAN STEERABLE INTRODUCER KITK120158CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITSK101015GUIDE CATHETERS AND ACCESSORIESK083269CROSSOVERK081341REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)K072745Y-GLIDE

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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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