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)

PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS

K-Number: K003925 · 2001-01-08

ApplicantCordis Neurovascular, Inc.
Decision Date2001-01-08
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Neurovascular, Inc.. It received FDA 510(k) clearance on 2001-01-08 under 510(k) number K003925. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS?

PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS is a medical device that received FDA 510(k) clearance on 2001-01-08. The listed applicant is Cordis Neurovascular, Inc.. The 510(k) number is K003925.

When did PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS receive FDA 510(k) clearance?

PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS received FDA 510(k) clearance on 2001-01-08, under 510(k) number K003925.

Who is the listed applicant for PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS?

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

What is the FDA product code for PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS?

The FDA product code for PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS is KRA.

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 Cordis Neurovascular, 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.

K082324TRUFILL DCS SYRINGEK080967TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBITK071962VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)K070279MODIFICATION TO HYPERTRANSIT INFUSION CATHETERK063254THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEMK053197TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION

View all 37 devices →

Related Devices (Code: KRA)

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.

K253509TriSalus TriNav Advance Infusion SystemTrisalus Life SciencesK254051Extroducer Infusion Catheter SystemSmartWise Sweden ABK261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific CorporationK250794InVera Infusion DeviceInvera MedicalK243534Micro CatheterSuzhou Zenith Vascular SciTech Limited

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.

↑