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FDA 510(k)

ADMIRAL XTREME PTA CATHETER

K-Number: K062809 · 2006-10-18

ApplicantInvatec Innovative Technologies
Decision Date2006-10-18
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ADMIRAL XTREME PTA CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Invatec Innovative Technologies. It received FDA 510(k) clearance on 2006-10-18 under 510(k) number K062809. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADMIRAL XTREME PTA CATHETER?

ADMIRAL XTREME PTA CATHETER is a medical device that received FDA 510(k) clearance on 2006-10-18. The listed applicant is Invatec Innovative Technologies. The 510(k) number is K062809.

When did ADMIRAL XTREME PTA CATHETER receive FDA 510(k) clearance?

ADMIRAL XTREME PTA CATHETER received FDA 510(k) clearance on 2006-10-18, under 510(k) number K062809.

Who is the listed applicant for ADMIRAL XTREME PTA CATHETER?

The FDA 510(k) record lists Invatec Innovative Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADMIRAL XTREME PTA CATHETER?

The FDA product code for ADMIRAL XTREME PTA CATHETER is DQY.

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Other records listing Invatec Innovative Technologies 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.

K042537SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SUVXXXXXXXXXK042538SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXX

Related Devices (Code: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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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