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FDA 510(k)

PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES

K-Number: K032146 · 2003-08-12

ApplicantPrecision Vascular Systems, Inc.
Decision Date2003-08-12
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES 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 2003-08-12 under 510(k) number K032146. 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 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES?

PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES is a medical device that received FDA 510(k) clearance on 2003-08-12. The listed applicant is Precision Vascular Systems, Inc.. The 510(k) number is K032146.

When did PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES receive FDA 510(k) clearance?

PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES received FDA 510(k) clearance on 2003-08-12, under 510(k) number K032146.

Who is the listed applicant for PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES?

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 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES?

The FDA product code for PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES is DQX.

Related Clinical Trials

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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 MICROCATHETERK023700PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIREK020733PVS 1500 SDSK002907PVS 1300 NEURO GUIDE WIREK002707PVS 1400 GUIDE WITE WITH HYDROPHILIC COATINGK990823PVS 1400 GUIDEWIRE

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Related Devices (Code: DQX)

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.

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.K253667Accoat Guide WireSp Medical A/SK261640Merit 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.

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