FDA 510(k)

PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE

K-Number: K023700 · 2002-12-04

ApplicantPrecision Vascular Systems, Inc.

Decision Date2002-12-04

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE 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 2002-12-04 under 510(k) number K023700. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE?

PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE is a medical device that received FDA 510(k) clearance on 2002-12-04. The listed applicant is Precision Vascular Systems, Inc.. The 510(k) number is K023700.

When did PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE receive FDA 510(k) clearance?

PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE received FDA 510(k) clearance on 2002-12-04, under 510(k) number K023700.

Who is the listed applicant for PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE?

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 1600 SYNCHRO 0.010 NEURO GUIDE WIRE?

The FDA product code for PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE is DQX.

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Other records listing Precision Vascular Systems, Inc. as applicant

K032494PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER K032146PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES K020733PVS 1500 SDS K002907PVS 1300 NEURO GUIDE WIRE K002707PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING K990823PVS 1400 GUIDEWIRE

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Related Devices (Code: DQX)

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.K253667Accoat Guide WireSp Medical A/S K261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.

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.