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FDA 510(k)

EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE

K-Number: K090364 · 2010-03-23

ApplicantAngioslide, Ltd.
Decision Date2010-03-23
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION 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 2010-03-23 under 510(k) number K090364. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE?

EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE is a medical device that received FDA 510(k) clearance on 2010-03-23. The listed applicant is Angioslide, Ltd.. The 510(k) number is K090364.

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

EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE received FDA 510(k) clearance on 2010-03-23, under 510(k) number K090364.

Who is the listed applicant for EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION 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 PROTECTION FEATURE?

The FDA product code for EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE is LIT.

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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 FEATUREK111750EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE

Related Devices (Code: LIT)

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.

K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd.K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.K260304WAVE PTA Balloon CatheterWAVE Medical AGK252512Armada™ 14 NC PTA CatheterABBOTT MEDICALK251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterBiotronik, Inc.

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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