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)

VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES

K-Number: K001926 · 2000-09-22

ApplicantThoratec Laboratories Corp.
Decision Date2000-09-22
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Thoratec Laboratories Corp.. It received FDA 510(k) clearance on 2000-09-22 under 510(k) number K001926. 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 VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES?

VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES is a medical device that received FDA 510(k) clearance on 2000-09-22. The listed applicant is Thoratec Laboratories Corp.. The 510(k) number is K001926.

When did VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES receive FDA 510(k) clearance?

VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES received FDA 510(k) clearance on 2000-09-22, under 510(k) number K001926.

Who is the listed applicant for VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES?

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

What is the FDA product code for VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES?

The FDA product code for VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES 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_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 Thoratec Laboratories 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.

K001927VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAMEK851495THORATEC MULTILUMEN CENTRAL VENOUS CATH-TRAYK833714RESPIRATORY ASSESSMENT SYSTEMK833265RESPIRATORY FLOW MODULEK831557INTRAOPERATIVE AUTOTRANSFUSION SYSK823449RESPIRATORY GAS ANALYZER

View all 10 devices →

Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture 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, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo 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.

↑