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FDA 510(k)

PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER

K-Number: K033726 · 2004-01-16

ApplicantPrecision Vascular
Decision Date2004-01-16
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Precision Vascular. It received FDA 510(k) clearance on 2004-01-16 under 510(k) number K033726. 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 PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER?

PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER is a medical device that received FDA 510(k) clearance on 2004-01-16. The listed applicant is Precision Vascular. The 510(k) number is K033726.

When did PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER receive FDA 510(k) clearance?

PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER received FDA 510(k) clearance on 2004-01-16, under 510(k) number K033726.

Who is the listed applicant for PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER?

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

What is the FDA product code for PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER?

The FDA product code for PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER is KRA.

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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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