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FDA 510(k)

POLYPLEX STIMULATING CATHETER SYSTEM

K-Number: K060186 · 2006-07-18

ApplicantTe ME NA Sas
Decision Date2006-07-18
Product CodeCAZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

POLYPLEX STIMULATING CATHETER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Te ME NA Sas. It received FDA 510(k) clearance on 2006-07-18 under 510(k) number K060186. The device is classified under product code CAZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYPLEX STIMULATING CATHETER SYSTEM?

POLYPLEX STIMULATING CATHETER SYSTEM is a medical device that received FDA 510(k) clearance on 2006-07-18. The listed applicant is Te ME NA Sas. The 510(k) number is K060186.

When did POLYPLEX STIMULATING CATHETER SYSTEM receive FDA 510(k) clearance?

POLYPLEX STIMULATING CATHETER SYSTEM received FDA 510(k) clearance on 2006-07-18, under 510(k) number K060186.

Who is the listed applicant for POLYPLEX STIMULATING CATHETER SYSTEM?

The FDA 510(k) record lists Te ME NA Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYPLEX STIMULATING CATHETER SYSTEM?

The FDA product code for POLYPLEX STIMULATING CATHETER SYSTEM is CAZ.

Related Clinical Trials

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Other records listing Te ME NA Sas 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.

K080603HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED

Related Devices (Code: CAZ)

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.

K261372Profoject™ LOR SyringeCMT Health PTE., Ltd.K222341Arrow 0.2 Micron Flat Filter, GVSArrow International, LLCK210983BD Epilor SyringeBecton, Dickinson and CompanyK201356Plastic LOR SyringeJiangsu Caina Medical Co.,LtdK202699E-Cath STIM acc. TsuiPAJUNK GmbH MedizintechnologieK190345VPCPAJUNK GmbH Medizintechnologie

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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