FDA 510(k)

6F & 7F INTRODUCING CATHETERS (MODIFICATION)

K-Number: K001135 · 2000-07-03

Decision Date2000-07-03

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

6F & 7F INTRODUCING CATHETERS (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 2000-07-03 under 510(k) number K001135. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 6F & 7F INTRODUCING CATHETERS (MODIFICATION)?

6F & 7F INTRODUCING CATHETERS (MODIFICATION) is a medical device that received FDA 510(k) clearance on 2000-07-03. The listed applicant is Cordis Corp.. The 510(k) number is K001135.

When did 6F & 7F INTRODUCING CATHETERS (MODIFICATION) receive FDA 510(k) clearance?

6F & 7F INTRODUCING CATHETERS (MODIFICATION) received FDA 510(k) clearance on 2000-07-03, under 510(k) number K001135.

Who is the listed applicant for 6F & 7F INTRODUCING CATHETERS (MODIFICATION)?

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 6F & 7F INTRODUCING CATHETERS (MODIFICATION)?

The FDA product code for 6F & 7F INTRODUCING CATHETERS (MODIFICATION) is DYB.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cordis Corp. as applicant

K112797POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER K101651ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE K082143MICRO GUIDE CATHETER XP K062798SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB K060877PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX K050645CORDIS AMIIA .014 PTA BALLOON CATHETER

View all 314 devices →

Related Devices (Code: DYB)

K253526NAMIC Dilator and SheathMedline Industries, LP K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLC K261242SimplGuidePendracare K261950Health Line Tearaway IntroducerHealth Line International Corporation K261492FieldFlex Steerable SheathCenterPoint Systems, LLC K260606Echo Large Bore Introducer SheathEcho Medical, LLC

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.