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FDA 510(k)

ECHOMARK PTA ULTRASONICALLY LOCATED BALLOON CATH.

K-Number: K903582 · 1990-11-06

ApplicantCatheter Sciences Co.
Decision Date1990-11-06
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECHOMARK PTA ULTRASONICALLY LOCATED BALLOON CATH. is the device name listed in this FDA 510(k) record. The listed applicant is Catheter Sciences Co.. It received FDA 510(k) clearance on 1990-11-06 under 510(k) number K903582. 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 ECHOMARK PTA ULTRASONICALLY LOCATED BALLOON CATH.?

ECHOMARK PTA ULTRASONICALLY LOCATED BALLOON CATH. is a medical device that received FDA 510(k) clearance on 1990-11-06. The listed applicant is Catheter Sciences Co.. The 510(k) number is K903582.

When did ECHOMARK PTA ULTRASONICALLY LOCATED BALLOON CATH. receive FDA 510(k) clearance?

ECHOMARK PTA ULTRASONICALLY LOCATED BALLOON CATH. received FDA 510(k) clearance on 1990-11-06, under 510(k) number K903582.

Who is the listed applicant for ECHOMARK PTA ULTRASONICALLY LOCATED BALLOON CATH.?

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

What is the FDA product code for ECHOMARK PTA ULTRASONICALLY LOCATED BALLOON CATH.?

The FDA product code for ECHOMARK PTA ULTRASONICALLY LOCATED BALLOON CATH. 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 Catheter Sciences Co. 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.

K910965ECHOMARK CSI INTERFACE

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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