Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210

K-Number: K982415 · 1998-08-10

ApplicantCordis Webster, Inc.
Decision Date1998-08-10
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210 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 1998-08-10 under 510(k) number K982415. 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 EXTERNAL REFERENCE PATCH, MODEL # D-1210?

CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210 is a medical device that received FDA 510(k) clearance on 1998-08-10. The listed applicant is Cordis Webster, Inc.. The 510(k) number is K982415.

When did CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210 receive FDA 510(k) clearance?

CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210 received FDA 510(k) clearance on 1998-08-10, under 510(k) number K982415.

Who is the listed applicant for CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210?

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 EXTERNAL REFERENCE PATCH, MODEL # D-1210?

The FDA product code for CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210 is DRF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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, 301-813SK980961CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.K970264CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEMK953663CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER

View all 10 devices →

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.

↑