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FDA 510(k)

HEARTPORT NEEDLE TROCAR

K-Number: K965051 · 1997-03-12

ApplicantHeartport, Inc.
Decision Date1997-03-12
Product CodeDRC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTPORT NEEDLE TROCAR is the device name listed in this FDA 510(k) record. The listed applicant is Heartport, Inc.. It received FDA 510(k) clearance on 1997-03-12 under 510(k) number K965051. 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 HEARTPORT NEEDLE TROCAR?

HEARTPORT NEEDLE TROCAR is a medical device that received FDA 510(k) clearance on 1997-03-12. The listed applicant is Heartport, Inc.. The 510(k) number is K965051.

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

HEARTPORT NEEDLE TROCAR received FDA 510(k) clearance on 1997-03-12, under 510(k) number K965051.

Who is the listed applicant for HEARTPORT NEEDLE TROCAR?

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

What is the FDA product code for HEARTPORT NEEDLE TROCAR?

The FDA product code for HEARTPORT NEEDLE TROCAR is DRC.

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Other records listing Heartport, 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.

K994243DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIPK981995QUICKDRAW VENOUS CANNULAK990772DIRECTFLOW ARTERIAL CANNULAK981009HEARTPORT ENDOPULMONARY VENT CATHETERK974736HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCERK974175HEARTPORT ENDOAORTIC CLAMP CATHETER

View all 24 devices →

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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