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FDA 510(k)

PRUITT VASCULAR SHUNT

K-Number: K801359 · 1980-07-28

ApplicantIdeas For Medicine, Inc.
Decision Date1980-07-28
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRUITT VASCULAR SHUNT is the device name listed in this FDA 510(k) record. The listed applicant is Ideas For Medicine, Inc.. It received FDA 510(k) clearance on 1980-07-28 under 510(k) number K801359. 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 PRUITT VASCULAR SHUNT?

PRUITT VASCULAR SHUNT is a medical device that received FDA 510(k) clearance on 1980-07-28. The listed applicant is Ideas For Medicine, Inc.. The 510(k) number is K801359.

When did PRUITT VASCULAR SHUNT receive FDA 510(k) clearance?

PRUITT VASCULAR SHUNT received FDA 510(k) clearance on 1980-07-28, under 510(k) number K801359.

Who is the listed applicant for PRUITT VASCULAR SHUNT?

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

What is the FDA product code for PRUITT VASCULAR SHUNT?

The FDA product code for PRUITT VASCULAR SHUNT is DWF.

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Other records listing Ideas For Medicine, 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.

K961883VERSA-CATH ARTERIAL CATHETERK962751IDEAS' DUAL PORTK961716VASO-SAFE ARTERIAL EMBOLECTOMY CATHETEK960715PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8FK960422PRUITT SAFETY OCCLUSION CATHETERK954713DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)

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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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