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FDA 510(k)

RIVETTI-LEVINSON INSTRALUMINAL SHUNT

K-Number: K972261 · 1997-09-15

ApplicantIntegra Neurocare, LLC
Decision Date1997-09-15
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RIVETTI-LEVINSON INSTRALUMINAL SHUNT is the device name listed in this FDA 510(k) record. The listed applicant is Integra Neurocare, LLC. It received FDA 510(k) clearance on 1997-09-15 under 510(k) number K972261. 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 RIVETTI-LEVINSON INSTRALUMINAL SHUNT?

RIVETTI-LEVINSON INSTRALUMINAL SHUNT is a medical device that received FDA 510(k) clearance on 1997-09-15. The listed applicant is Integra Neurocare, LLC. The 510(k) number is K972261.

When did RIVETTI-LEVINSON INSTRALUMINAL SHUNT receive FDA 510(k) clearance?

RIVETTI-LEVINSON INSTRALUMINAL SHUNT received FDA 510(k) clearance on 1997-09-15, under 510(k) number K972261.

Who is the listed applicant for RIVETTI-LEVINSON INSTRALUMINAL SHUNT?

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

What is the FDA product code for RIVETTI-LEVINSON INSTRALUMINAL SHUNT?

The FDA product code for RIVETTI-LEVINSON INSTRALUMINAL SHUNT is DWF.

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Other records listing Integra Neurocare, LLC 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.

K002392VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-VK992006NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33K981246BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)K973525MAURICE WORLDWIDE SHUNT SYSTEMK972994EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMSK971617ENDOSCOPIC VENTRICULAR CATHETER

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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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