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FDA 510(k)

NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS

K-Number: K961717 · 1996-07-18

ApplicantNaltiac Medical, Inc.
Decision Date1996-07-18
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS is the device name listed in this FDA 510(k) record. The listed applicant is Naltiac Medical, Inc.. It received FDA 510(k) clearance on 1996-07-18 under 510(k) number K961717. 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 NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS?

NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS is a medical device that received FDA 510(k) clearance on 1996-07-18. The listed applicant is Naltiac Medical, Inc.. The 510(k) number is K961717.

When did NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS receive FDA 510(k) clearance?

NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS received FDA 510(k) clearance on 1996-07-18, under 510(k) number K961717.

Who is the listed applicant for NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS?

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

What is the FDA product code for NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS?

The FDA product code for NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS is DWF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Naltiac Medical, 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.

K961181NMI VEIN GRAFT PERFUSION SETK961180NMI ANTEGRAD CARDIOPLEGIA CANNULA

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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