FDA 510(k)

CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085

K-Number: K992965 · 1999-11-26

Decision Date1999-11-26

Product CodeDRF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085 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 1999-11-26 under 510(k) number K992965. 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 FIXED CURVE CATHETERS, MODELS D-1124, D-1085?

CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085 is a medical device that received FDA 510(k) clearance on 1999-11-26. The listed applicant is Cordis Webster, Inc.. The 510(k) number is K992965.

When did CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085 receive FDA 510(k) clearance?

CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085 received FDA 510(k) clearance on 1999-11-26, under 510(k) number K992965.

Who is the listed applicant for CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085?

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 FIXED CURVE CATHETERS, MODELS D-1124, D-1085?

The FDA product code for CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085 is DRF.

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Other records listing Cordis Webster, Inc. as applicant

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 K980961CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.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.