FDA 510(k)

True Flow Valvuloplasty Perfusion Catheter

K-Number: K152613 · 2016-01-19

Decision Date2016-01-19

Product CodeOZT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

True Flow Valvuloplasty Perfusion Catheter is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2016-01-19 under 510(k) number K152613. The device is classified under product code OZT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the True Flow Valvuloplasty Perfusion Catheter?

True Flow Valvuloplasty Perfusion Catheter is a medical device that received FDA 510(k) clearance on 2016-01-19. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K152613.

When did True Flow Valvuloplasty Perfusion Catheter receive FDA 510(k) clearance?

True Flow Valvuloplasty Perfusion Catheter received FDA 510(k) clearance on 2016-01-19, under 510(k) number K152613.

Who is the listed applicant for True Flow Valvuloplasty Perfusion Catheter?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for True Flow Valvuloplasty Perfusion Catheter?

The FDA product code for True Flow Valvuloplasty Perfusion Catheter is OZT.

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.

NCT03911700Prophylactic Reinforcement of Ventral Abdominal Incisions TrialACTIVE_NOT_RECRUITING NCT04634916Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF SystemRECRUITING NCT05711316The BD Liverty™ TIPS Stent Graft StudyACTIVE_NOT_RECRUITING NCT05945329Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant AugmentationRECRUITING NCT07282860An Evaluation of the PureWick™ Male External Catheter Versus an Established Comparator Overnight in the Home Setting for Incontinence in Adult MalesCOMPLETED NCT07744945Evaluation of Male and Female External Catheters for Urine Output Monitoring in the ICUNOT_YET_RECRUITING

Other records listing C.R. Bard, Inc. as applicant

PMA P800002Agent, absorbable hemostatic, collagen based K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)PMA P170042System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit K252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)K251864Rubber Utility Catheter

View all 74 devices →

Related Devices (Code: OZT)

K253855KardiaPSI Balloon CatheterIntervention Tech, Inc. ; dba Corvention K260437Valvuloplasty Balloon Catheter (ValvuloPro)Dongguan TT Medical, Inc.K241562OutFlo Aortic Valve Dilatation Balloon CatheterDisa Medinotec K240967ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc.K231814ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc.K220881INOUE BALLOON AToray Industries, 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.