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FDA 510(k)

PVS 1500 SDS

K-Number: K020733 · 2002-03-21

ApplicantPrecision Vascular Systems, Inc.
Decision Date2002-03-21
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PVS 1500 SDS is the device name listed in this FDA 510(k) record. The listed applicant is Precision Vascular Systems, Inc.. It received FDA 510(k) clearance on 2002-03-21 under 510(k) number K020733. 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 1500 SDS?

PVS 1500 SDS is a medical device that received FDA 510(k) clearance on 2002-03-21. The listed applicant is Precision Vascular Systems, Inc.. The 510(k) number is K020733.

When did PVS 1500 SDS receive FDA 510(k) clearance?

PVS 1500 SDS received FDA 510(k) clearance on 2002-03-21, under 510(k) number K020733.

Who is the listed applicant for PVS 1500 SDS?

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

What is the FDA product code for PVS 1500 SDS?

The FDA product code for PVS 1500 SDS is KRA.

Other records listing Precision Vascular Systems, 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.

K032494PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETERK032146PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRESK023700PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIREK002907PVS 1300 NEURO GUIDE WIREK002707PVS 1400 GUIDE WITE WITH HYDROPHILIC COATINGK990823PVS 1400 GUIDEWIRE

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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

View on FDA Database →

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

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