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FDA 510(k)

AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR

K-Number: K081820 · 2008-10-06

ApplicantAvalon Laboratories, LLC
Decision Date2008-10-06
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR is the device name listed in this FDA 510(k) record. The listed applicant is Avalon Laboratories, LLC. It received FDA 510(k) clearance on 2008-10-06 under 510(k) number K081820. 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 AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR?

AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR is a medical device that received FDA 510(k) clearance on 2008-10-06. The listed applicant is Avalon Laboratories, LLC. The 510(k) number is K081820.

When did AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR receive FDA 510(k) clearance?

AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR received FDA 510(k) clearance on 2008-10-06, under 510(k) number K081820.

Who is the listed applicant for AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR?

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

What is the FDA product code for AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR?

The FDA product code for AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR 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.

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Other records listing Avalon Laboratories, 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.

K081940AVALON ELITE VASCULAR ACCESS KITK081933AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR

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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