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FDA 510(k)

CORDIS WESTER STAR CATHETER

K-Number: K954390 · 1995-12-21

ApplicantCordis Webster, Inc.
Decision Date1995-12-21
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORDIS WESTER STAR CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Webster, Inc.. It received FDA 510(k) clearance on 1995-12-21 under 510(k) number K954390. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORDIS WESTER STAR CATHETER?

CORDIS WESTER STAR CATHETER is a medical device that received FDA 510(k) clearance on 1995-12-21. The listed applicant is Cordis Webster, Inc.. The 510(k) number is K954390.

When did CORDIS WESTER STAR CATHETER receive FDA 510(k) clearance?

CORDIS WESTER STAR CATHETER received FDA 510(k) clearance on 1995-12-21, under 510(k) number K954390.

Who is the listed applicant for CORDIS WESTER STAR CATHETER?

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

What is the FDA product code for CORDIS WESTER STAR CATHETER?

The FDA product code for CORDIS WESTER STAR CATHETER is DRF.

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Other records listing Cordis Webster, 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.

K992965CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085K991531CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078K982740CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813SK982415CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210K980961CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.K970264CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM

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Related Devices (Code: DRF)

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.

K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific CorporationK240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific CorporationK233900Nordica PV Cryo Mapping CatheterSynaptic Medical CorporationK233397Cosine-10TM Diagnostic CatheterMedtronic, 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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