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FDA 510(k)

MODIFIED PERIPHERAL DILATATION CATHETERS

K-Number: K875175 · 1988-07-28

ApplicantSchneider-Shilley (Usa)
Decision Date1988-07-28
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED PERIPHERAL DILATATION CATHETERS 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 1988-07-28 under 510(k) number K875175. 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 MODIFIED PERIPHERAL DILATATION CATHETERS?

MODIFIED PERIPHERAL DILATATION CATHETERS is a medical device that received FDA 510(k) clearance on 1988-07-28. The listed applicant is Schneider-Shilley (Usa). The 510(k) number is K875175.

When did MODIFIED PERIPHERAL DILATATION CATHETERS receive FDA 510(k) clearance?

MODIFIED PERIPHERAL DILATATION CATHETERS received FDA 510(k) clearance on 1988-07-28, under 510(k) number K875175.

Who is the listed applicant for MODIFIED PERIPHERAL DILATATION CATHETERS?

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 MODIFIED PERIPHERAL DILATATION CATHETERS?

The FDA product code for MODIFIED PERIPHERAL DILATATION CATHETERS 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.

K882826SOFTRAC-PTA PERIPHERAL DILATATION CATHETERK881197SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETERK875323MODIFIED SCHNEIDER-SHILEY WIRE TORQUERK875322MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETERK875327MODIFIED 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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