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)

RETROFLEX DILATOR KIT

K-Number: K093554 · 2010-04-13

ApplicantEdwards Lifesciences, LLC
Decision Date2010-04-13
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RETROFLEX DILATOR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2010-04-13 under 510(k) number K093554. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RETROFLEX DILATOR KIT?

RETROFLEX DILATOR KIT is a medical device that received FDA 510(k) clearance on 2010-04-13. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K093554.

When did RETROFLEX DILATOR KIT receive FDA 510(k) clearance?

RETROFLEX DILATOR KIT received FDA 510(k) clearance on 2010-04-13, under 510(k) number K093554.

Who is the listed applicant for RETROFLEX DILATOR KIT?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RETROFLEX DILATOR KIT?

The FDA product code for RETROFLEX DILATOR KIT is DRE.

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 Edwards Lifesciences, LLC 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.

K251326Respiration Rate algorithmK253186HemoSphere Nano Monitor (HSNANO1)K251982Edwards MC3 Tricuspid annuloplasty ring (4900)K251688Carpentier-Edwards Physio Annuloplasty Ring (4450)K242518Hypertension Prediction Index (HePI) AlgorithmK242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors

View all 122 devices →

Related Devices (Code: DRE)

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.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, 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.

↑