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FDA 510(k)

SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER

K-Number: K902091 · 1990-09-26

ApplicantSchneider Intl., Ltd.
Decision Date1990-09-26
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Schneider Intl., Ltd.. It received FDA 510(k) clearance on 1990-09-26 under 510(k) number K902091. 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 SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER?

SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER is a medical device that received FDA 510(k) clearance on 1990-09-26. The listed applicant is Schneider Intl., Ltd.. The 510(k) number is K902091.

When did SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER receive FDA 510(k) clearance?

SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER received FDA 510(k) clearance on 1990-09-26, under 510(k) number K902091.

Who is the listed applicant for SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER?

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

What is the FDA product code for SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER?

The FDA product code for SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER is LIT.

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Other records listing Schneider Intl., 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.

K925406BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEMK931577SCHNEIDER MAGNUM PERIPHERAL RECANALIZATION GUIDEWIK926271SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIOK926003SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETERK925804SCHNEIDER HYDRO-SIL GUIDEWIREK924591SCHNEIDER SOLID-7 SOPTIP GUIDING CATHETER

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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