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FDA 510(k)

ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER

K-Number: K090822 · 2009-04-27

ApplicantCook, Inc.
Decision Date2009-04-27
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ADVANCE 14RX RAPID EXCHANGE PTA BALLOON 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 2009-04-27 under 510(k) number K090822. 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 ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER?

ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2009-04-27. The listed applicant is Cook, Inc.. The 510(k) number is K090822.

When did ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER receive FDA 510(k) clearance?

ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER received FDA 510(k) clearance on 2009-04-27, under 510(k) number K090822.

Who is the listed applicant for ADVANCE 14RX RAPID EXCHANGE PTA BALLOON 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 ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER?

The FDA product code for ADVANCE 14RX RAPID EXCHANGE PTA BALLOON 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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