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FDA 510(k)

TRUMPET VALVE HANDLE WITH 3-METRE TUBING, SINGLE SPIKE, 5MM CANNULA, TRUMPET VALVE HANDLE WITH 3-METRE TUBING, DOUBLE

K-Number: K060182 · 2006-09-07

ApplicantAustralian Surgical Devices
Decision Date2006-09-07
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TRUMPET VALVE HANDLE WITH 3-METRE TUBING, SINGLE SPIKE, 5MM CANNULA, TRUMPET VALVE HANDLE WITH 3-METRE TUBING, DOUBLE is the device name listed in this FDA 510(k) record. The listed applicant is Australian Surgical Devices. It received FDA 510(k) clearance on 2006-09-07 under 510(k) number K060182. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUMPET VALVE HANDLE WITH 3-METRE TUBING, SINGLE SPIKE, 5MM CANNULA, TRUMPET VALVE HANDLE WITH 3-METRE TUBING, DOUBLE?

TRUMPET VALVE HANDLE WITH 3-METRE TUBING, SINGLE SPIKE, 5MM CANNULA, TRUMPET VALVE HANDLE WITH 3-METRE TUBING, DOUBLE is a medical device that received FDA 510(k) clearance on 2006-09-07. The listed applicant is Australian Surgical Devices. The 510(k) number is K060182.

When did TRUMPET VALVE HANDLE WITH 3-METRE TUBING, SINGLE SPIKE, 5MM CANNULA, TRUMPET VALVE HANDLE WITH 3-METRE TUBING, DOUBLE receive FDA 510(k) clearance?

TRUMPET VALVE HANDLE WITH 3-METRE TUBING, SINGLE SPIKE, 5MM CANNULA, TRUMPET VALVE HANDLE WITH 3-METRE TUBING, DOUBLE received FDA 510(k) clearance on 2006-09-07, under 510(k) number K060182.

Who is the listed applicant for TRUMPET VALVE HANDLE WITH 3-METRE TUBING, SINGLE SPIKE, 5MM CANNULA, TRUMPET VALVE HANDLE WITH 3-METRE TUBING, DOUBLE?

The FDA 510(k) record lists Australian Surgical Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRUMPET VALVE HANDLE WITH 3-METRE TUBING, SINGLE SPIKE, 5MM CANNULA, TRUMPET VALVE HANDLE WITH 3-METRE TUBING, DOUBLE?

The FDA product code for TRUMPET VALVE HANDLE WITH 3-METRE TUBING, SINGLE SPIKE, 5MM CANNULA, TRUMPET VALVE HANDLE WITH 3-METRE TUBING, DOUBLE is GCJ.

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Related Devices (Code: GCJ)

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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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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