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FDA 510(k)

PTA-DUO PTA BALLOON CATHETER

K-Number: K101047 · 2010-07-13

ApplicantHotspur Technologies
Decision Date2010-07-13
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PTA-DUO PTA BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Hotspur Technologies. It received FDA 510(k) clearance on 2010-07-13 under 510(k) number K101047. 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 PTA-DUO PTA BALLOON CATHETER?

PTA-DUO PTA BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2010-07-13. The listed applicant is Hotspur Technologies. The 510(k) number is K101047.

When did PTA-DUO PTA BALLOON CATHETER receive FDA 510(k) clearance?

PTA-DUO PTA BALLOON CATHETER received FDA 510(k) clearance on 2010-07-13, under 510(k) number K101047.

Who is the listed applicant for PTA-DUO PTA BALLOON CATHETER?

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

What is the FDA product code for PTA-DUO PTA BALLOON CATHETER?

The FDA product code for PTA-DUO PTA BALLOON CATHETER is LIT.

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Other records listing Hotspur Technologies 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.

K130397ARROW GPSCATH BALLOON DILATATION CATHETERK113769GPSCATH BALLON DILATATION CATHETERK100842PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CMK100840EMBO PLUS EMBOLECTOMY CATHETER

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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