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FDA 510(k)

MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING

K-Number: K953691 · 1995-10-16

ApplicantMeadox Medicals, Div. Boston Scientific Corp.
Decision Date1995-10-16
Product CodeEZN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING 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 1995-10-16 under 510(k) number K953691. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING?

MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING is a medical device that received FDA 510(k) clearance on 1995-10-16. The listed applicant is Meadox Medicals, Div. Boston Scientific Corp.. The 510(k) number is K953691.

When did MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING receive FDA 510(k) clearance?

MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING received FDA 510(k) clearance on 1995-10-16, under 510(k) number K953691.

Who is the listed applicant for MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING?

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 CATHETER W/HYDROPASS COATING?

The FDA product code for MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING is EZN.

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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: EZN)

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.

K250910Optilume® High Pressure Urological Balloon Dilation CatheterUrotronic, Inc.K220781ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer CatheterAllwin Medical Devices, Inc.K201007In-Ka Ureteral Balloon Dilatation CatheterColoplast Corp.K190612EQUINOX Balloon Dilatation CatheterDornier Medtech America, Inc.K173654Ureteral Dilator Sets, Ureteral DilatorsCook IncorporatedK180756Safety Wire Guide IntroducerCook Incorporated

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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