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FDA 510(k)

EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE

K-Number: K111750 · 2011-07-21

ApplicantAngioslide, Ltd.
Decision Date2011-07-21
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE is the device name listed in this FDA 510(k) record. The listed applicant is Angioslide, Ltd.. It received FDA 510(k) clearance on 2011-07-21 under 510(k) number K111750. 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 EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE?

EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE is a medical device that received FDA 510(k) clearance on 2011-07-21. The listed applicant is Angioslide, Ltd.. The 510(k) number is K111750.

When did EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE receive FDA 510(k) clearance?

EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE received FDA 510(k) clearance on 2011-07-21, under 510(k) number K111750.

Who is the listed applicant for EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE?

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

What is the FDA product code for EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE?

The FDA product code for EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE is DQY.

Related Clinical Trials

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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Other records listing Angioslide, Ltd. 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.

K172494PROTEUS PTA Balloon Catheter with Embolic Capture FeatureK133043PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATUREK120164PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATUREK120805PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATUREK090364EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE

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, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

Official Source

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