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FDA 510(k)

CORDIS 13F CATHETER SHEATH INTRODUCER

K-Number: K000753 · 2000-04-06

ApplicantCordis Corp.
Decision Date2000-04-06
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORDIS 13F CATHETER SHEATH INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 2000-04-06 under 510(k) number K000753. 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 13F CATHETER SHEATH INTRODUCER?

CORDIS 13F CATHETER SHEATH INTRODUCER is a medical device that received FDA 510(k) clearance on 2000-04-06. The listed applicant is Cordis Corp.. The 510(k) number is K000753.

When did CORDIS 13F CATHETER SHEATH INTRODUCER receive FDA 510(k) clearance?

CORDIS 13F CATHETER SHEATH INTRODUCER received FDA 510(k) clearance on 2000-04-06, under 510(k) number K000753.

Who is the listed applicant for CORDIS 13F CATHETER SHEATH INTRODUCER?

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

What is the FDA product code for CORDIS 13F CATHETER SHEATH INTRODUCER?

The FDA product code for CORDIS 13F CATHETER SHEATH INTRODUCER is DRF.

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Other records listing Cordis 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.

K112797POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETERK101651ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIREK082143MICRO GUIDE CATHETER XPK062798SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MBK060877PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAXK050645CORDIS AMIIA .014 PTA BALLOON CATHETER

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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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