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FDA 510(k)

ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER

K-Number: K033875 · 2004-04-02

ApplicantCook, Inc.
Decision Date2004-04-02
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 2004-04-02 under 510(k) number K033875. 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 ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER?

ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2004-04-02. The listed applicant is Cook, Inc.. The 510(k) number is K033875.

When did ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER receive FDA 510(k) clearance?

ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER received FDA 510(k) clearance on 2004-04-02, under 510(k) number K033875.

Who is the listed applicant for ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER?

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

What is the FDA product code for ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER?

The FDA product code for ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER is DQY.

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Other records listing Cook, Inc. 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.

K133634SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SETK132020ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETERK131201ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SETK131206COOK CERVICAL RIPENING BALLOONK132334TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SETK122091COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY

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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.

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

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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