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FDA 510(k)

MS CLASSIQUE BALLOON DIATATION CATHETER

K-Number: K953298 · 1996-02-08

ApplicantMeadox Medicals, Div. Boston Scientific Corp.
Decision Date1996-02-08
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MS CLASSIQUE BALLOON DIATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Meadox Medicals, Div. Boston Scientific Corp.. It received FDA 510(k) clearance on 1996-02-08 under 510(k) number K953298. 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 MS CLASSIQUE BALLOON DIATATION CATHETER?

MS CLASSIQUE BALLOON DIATATION CATHETER is a medical device that received FDA 510(k) clearance on 1996-02-08. The listed applicant is Meadox Medicals, Div. Boston Scientific Corp.. The 510(k) number is K953298.

When did MS CLASSIQUE BALLOON DIATATION CATHETER receive FDA 510(k) clearance?

MS CLASSIQUE BALLOON DIATATION CATHETER received FDA 510(k) clearance on 1996-02-08, under 510(k) number K953298.

Who is the listed applicant for MS CLASSIQUE BALLOON DIATATION CATHETER?

The FDA 510(k) record lists Meadox Medicals, Div. Boston Scientific Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MS CLASSIQUE BALLOON DIATATION CATHETER?

The FDA product code for MS CLASSIQUE BALLOON DIATATION CATHETER is LIT.

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Other records listing Meadox Medicals, Div. Boston Scientific Corp. 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.

K953647MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATINGK960766MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFTK962433MEADOX EXXCEL EPTFE VASCULAR GRAFTK961847HEMASHIELD VANTAGE (VASCULAR GRAFTK962342HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCHK955460MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT

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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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