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FDA 510(k)

SOFTRAC-PTA PERIPHERAL DILATATION CATHETER

K-Number: K882826 · 1989-01-24

ApplicantSchneider-Shilley (Usa)
Decision Date1989-01-24
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOFTRAC-PTA PERIPHERAL DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Schneider-Shilley (Usa). It received FDA 510(k) clearance on 1989-01-24 under 510(k) number K882826. 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 SOFTRAC-PTA PERIPHERAL DILATATION CATHETER?

SOFTRAC-PTA PERIPHERAL DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 1989-01-24. The listed applicant is Schneider-Shilley (Usa). The 510(k) number is K882826.

When did SOFTRAC-PTA PERIPHERAL DILATATION CATHETER receive FDA 510(k) clearance?

SOFTRAC-PTA PERIPHERAL DILATATION CATHETER received FDA 510(k) clearance on 1989-01-24, under 510(k) number K882826.

Who is the listed applicant for SOFTRAC-PTA PERIPHERAL DILATATION CATHETER?

The FDA 510(k) record lists Schneider-Shilley (Usa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOFTRAC-PTA PERIPHERAL DILATATION CATHETER?

The FDA product code for SOFTRAC-PTA PERIPHERAL DILATATION CATHETER is LIT.

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Other records listing Schneider-Shilley (Usa) 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.

K875175MODIFIED PERIPHERAL DILATATION CATHETERSK881197SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETERK875322MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETERK875323MODIFIED SCHNEIDER-SHILEY WIRE TORQUERK875327MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENTK875324MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES

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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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