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FDA 510(k)

GPSCATH BALLON DILATATION CATHETER

K-Number: K113769 · 2012-01-20

ApplicantHotspur Technologies
Decision Date2012-01-20
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GPSCATH BALLON DILATATION 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 2012-01-20 under 510(k) number K113769. 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 GPSCATH BALLON DILATATION CATHETER?

GPSCATH BALLON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2012-01-20. The listed applicant is Hotspur Technologies. The 510(k) number is K113769.

When did GPSCATH BALLON DILATATION CATHETER receive FDA 510(k) clearance?

GPSCATH BALLON DILATATION CATHETER received FDA 510(k) clearance on 2012-01-20, under 510(k) number K113769.

Who is the listed applicant for GPSCATH BALLON DILATATION 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 GPSCATH BALLON DILATATION CATHETER?

The FDA product code for GPSCATH BALLON DILATATION CATHETER is LIT.

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 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 CATHETERK101047PTA-DUO PTA BALLOON 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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