FDA 510(k)

CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.

K-Number: K980961 · 1998-05-28

Decision Date1998-05-28

Product CodeDRF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04. 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 1998-05-28 under 510(k) number K980961. 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 WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.?

CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04. is a medical device that received FDA 510(k) clearance on 1998-05-28. The listed applicant is Cordis Webster, Inc.. The 510(k) number is K980961.

When did CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04. receive FDA 510(k) clearance?

CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04. received FDA 510(k) clearance on 1998-05-28, under 510(k) number K980961.

Who is the listed applicant for CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.?

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 WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.?

The FDA product code for CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04. is DRF.

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Other records listing Cordis Webster, Inc. as applicant

K992965CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085 K991531CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078 K982740CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S K982415CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210 K970264CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM K953663CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER

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Related Devices (Code: DRF)

K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific Corporation K240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific Corporation K233900Nordica PV Cryo Mapping CatheterSynaptic Medical Corporation K233397Cosine-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.