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FDA 510(k)

OCCLUSION BALLOON CATHETER

K-Number: K070126 · 2008-02-08

ApplicantSentreheart, Inc.
Decision Date2008-02-08
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OCCLUSION BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Sentreheart, Inc.. It received FDA 510(k) clearance on 2008-02-08 under 510(k) number K070126. 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 OCCLUSION BALLOON CATHETER?

OCCLUSION BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2008-02-08. The listed applicant is Sentreheart, Inc.. The 510(k) number is K070126.

When did OCCLUSION BALLOON CATHETER receive FDA 510(k) clearance?

OCCLUSION BALLOON CATHETER received FDA 510(k) clearance on 2008-02-08, under 510(k) number K070126.

Who is the listed applicant for OCCLUSION BALLOON CATHETER?

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

What is the FDA product code for OCCLUSION BALLOON CATHETER?

The FDA product code for OCCLUSION BALLOON CATHETER is DQY.

Related Clinical Trials

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Other records listing Sentreheart, 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.

K090385LARIAT II SUTURE DELIVERY DEVICEK080364FINDRWIRZ GUIDE WIRE SYSTEM

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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