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)

CATALYST II AND III

K-Number: K130124 · 2013-03-14

ApplicantCardiva Medical, Inc.
Decision Date2013-03-14
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CATALYST II AND III is the device name listed in this FDA 510(k) record. The listed applicant is Cardiva Medical, Inc.. It received FDA 510(k) clearance on 2013-03-14 under 510(k) number K130124. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATALYST II AND III?

CATALYST II AND III is a medical device that received FDA 510(k) clearance on 2013-03-14. The listed applicant is Cardiva Medical, Inc.. The 510(k) number is K130124.

When did CATALYST II AND III receive FDA 510(k) clearance?

CATALYST II AND III received FDA 510(k) clearance on 2013-03-14, under 510(k) number K130124.

Who is the listed applicant for CATALYST II AND III?

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

What is the FDA product code for CATALYST II AND III?

The FDA product code for CATALYST II AND III is DXC.

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 Cardiva Medical, Inc. 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.

K082930CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATEK072297BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEMK070485BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58LK051817BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEMK061075BOOMERANG WIREK041486VASOSTASIS VASCULAR CLOSURE SYSTEM

View all 7 devices →

Related Devices (Code: DXC)

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.

K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards LifesciencesK252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.K254060Life Saving TourniquetTW MedicalK243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLCK253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LP

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.

↑