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FDA 510(k)

FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH

K-Number: K033569 · 2004-01-13

ApplicantFlowmedica, Inc.
Decision Date2004-01-13
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Flowmedica, Inc.. It received FDA 510(k) clearance on 2004-01-13 under 510(k) number K033569. 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 FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH?

FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH is a medical device that received FDA 510(k) clearance on 2004-01-13. The listed applicant is Flowmedica, Inc.. The 510(k) number is K033569.

When did FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH receive FDA 510(k) clearance?

FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH received FDA 510(k) clearance on 2004-01-13, under 510(k) number K033569.

Who is the listed applicant for FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH?

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

What is the FDA product code for FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH?

The FDA product code for FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH 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.

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Other records listing Flowmedica, 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.

K082163FLOWMEDICA BENEPHIT INFUSION SYSTEMSK050205BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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