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FDA 510(k)

ACS SCHWARTEN XT BALLOON DILATATION CATHETER

K-Number: K882925 · 1988-09-28

ApplicantAdvanced Cardiovascular Systems, Inc.
Decision Date1988-09-28
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACS SCHWARTEN XT BALLOON DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 1988-09-28 under 510(k) number K882925. 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 ACS SCHWARTEN XT BALLOON DILATATION CATHETER?

ACS SCHWARTEN XT BALLOON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 1988-09-28. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K882925.

When did ACS SCHWARTEN XT BALLOON DILATATION CATHETER receive FDA 510(k) clearance?

ACS SCHWARTEN XT BALLOON DILATATION CATHETER received FDA 510(k) clearance on 1988-09-28, under 510(k) number K882925.

Who is the listed applicant for ACS SCHWARTEN XT BALLOON DILATATION CATHETER?

The FDA 510(k) record lists Advanced Cardiovascular Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACS SCHWARTEN XT BALLOON DILATATION CATHETER?

The FDA product code for ACS SCHWARTEN XT BALLOON DILATATION CATHETER is LIT.

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Other records listing Advanced Cardiovascular Systems, Inc. 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.

K012534HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATINGK000550OTW MEGALINK SDS BILIARY STENT SYSTEMK994229VERIPATH PERIPHERAL GUIDING CATHETERK992169ACS HI-TORQUE CROSS-IT 400XT GUIDE WIREK990867RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18K963702ACS HI-TORQUE IRON MAN GUIDE WIRE

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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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