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FDA 510(k)

AVIATOR PERIPHERAL DILATATION CATHETER

K-Number: K010831 · 2001-06-13

ApplicantGuidant Corp.
Decision Date2001-06-13
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AVIATOR PERIPHERAL DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Guidant Corp.. It received FDA 510(k) clearance on 2001-06-13 under 510(k) number K010831. 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 AVIATOR PERIPHERAL DILATATION CATHETER?

AVIATOR PERIPHERAL DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2001-06-13. The listed applicant is Guidant Corp.. The 510(k) number is K010831.

When did AVIATOR PERIPHERAL DILATATION CATHETER receive FDA 510(k) clearance?

AVIATOR PERIPHERAL DILATATION CATHETER received FDA 510(k) clearance on 2001-06-13, under 510(k) number K010831.

Who is the listed applicant for AVIATOR PERIPHERAL DILATATION CATHETER?

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

What is the FDA product code for AVIATOR PERIPHERAL DILATATION CATHETER?

The FDA product code for AVIATOR PERIPHERAL DILATATION CATHETER is DQY.

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Other records listing Guidant Corp. as applicant

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K061865FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05K061453HI-TORQUE WHISPER VIEW GUIDE WIREK042908RX ACCUNET 2 EMBOLIC PROTECTION SYSTEMK042218ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEMK033834OMNILINK .018 BILIARY STENT SYSTEMK033393ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM

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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.

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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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