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FDA 510(k)

HEARTPORT ENDOCORONARY SINUS CATHETR

K-Number: K964248 · 1997-01-22

ApplicantHeartport, Inc.
Decision Date1997-01-22
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTPORT ENDOCORONARY SINUS CATHETR is the device name listed in this FDA 510(k) record. The listed applicant is Heartport, Inc.. It received FDA 510(k) clearance on 1997-01-22 under 510(k) number K964248. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEARTPORT ENDOCORONARY SINUS CATHETR?

HEARTPORT ENDOCORONARY SINUS CATHETR is a medical device that received FDA 510(k) clearance on 1997-01-22. The listed applicant is Heartport, Inc.. The 510(k) number is K964248.

When did HEARTPORT ENDOCORONARY SINUS CATHETR receive FDA 510(k) clearance?

HEARTPORT ENDOCORONARY SINUS CATHETR received FDA 510(k) clearance on 1997-01-22, under 510(k) number K964248.

Who is the listed applicant for HEARTPORT ENDOCORONARY SINUS CATHETR?

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 ENDOCORONARY SINUS CATHETR?

The FDA product code for HEARTPORT ENDOCORONARY SINUS CATHETR is DWF.

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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: DWF)

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.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, Inc.

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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