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)

ReVive PV (Peripheral Vasculature) Thrombectomy Device

K-Number: K132281 · 2013-08-30

ApplicantCodman & Shurtleff, Inc.
Decision Date2013-08-30
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ReVive PV (Peripheral Vasculature) Thrombectomy Device is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2013-08-30 under 510(k) number K132281. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ReVive PV (Peripheral Vasculature) Thrombectomy Device?

ReVive PV (Peripheral Vasculature) Thrombectomy Device is a medical device that received FDA 510(k) clearance on 2013-08-30. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K132281.

When did ReVive PV (Peripheral Vasculature) Thrombectomy Device receive FDA 510(k) clearance?

ReVive PV (Peripheral Vasculature) Thrombectomy Device received FDA 510(k) clearance on 2013-08-30, under 510(k) number K132281.

Who is the listed applicant for ReVive PV (Peripheral Vasculature) Thrombectomy Device?

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

What is the FDA product code for ReVive PV (Peripheral Vasculature) Thrombectomy Device?

The FDA product code for ReVive PV (Peripheral Vasculature) Thrombectomy Device is QEW.

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 Codman & Shurtleff, 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.

K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetK191237CERENOVUS Large Bore CatheterK173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter KitK172537Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection BagK172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)K171862GALAXY G3 Mini Microcoil Delivery System

View all 147 devices →

Related Devices (Code: QEW)

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.

K253419Triever Duo CatheterInari Medical, Inc.K261800Helo Max Thrombectomy System (HEL2090)Endovascular EngineeringK262538Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc.K261523Vertex™ Thrombectomy SystemJupiter EndovascularK260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration CanisterArgon Medical Devices, 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.

↑