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FDA 510(k)

PVS 2000 SYNCHRO2 GUIDEWIRE

K-Number: K053268 · 2006-03-13

ApplicantBoston Scientific - Precision Vascular
Decision Date2006-03-13
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PVS 2000 SYNCHRO2 GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific - Precision Vascular. It received FDA 510(k) clearance on 2006-03-13 under 510(k) number K053268. 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 2000 SYNCHRO2 GUIDEWIRE?

PVS 2000 SYNCHRO2 GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2006-03-13. The listed applicant is Boston Scientific - Precision Vascular. The 510(k) number is K053268.

When did PVS 2000 SYNCHRO2 GUIDEWIRE receive FDA 510(k) clearance?

PVS 2000 SYNCHRO2 GUIDEWIRE received FDA 510(k) clearance on 2006-03-13, under 510(k) number K053268.

Who is the listed applicant for PVS 2000 SYNCHRO2 GUIDEWIRE?

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

What is the FDA product code for PVS 2000 SYNCHRO2 GUIDEWIRE?

The FDA product code for PVS 2000 SYNCHRO2 GUIDEWIRE is DQX.

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 Boston Scientific - Precision Vascular 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.

K050964PV 1900 SYNCHRO 0.016 GUIDEWIREK050630PIVOT STEERABLE MICROCATHETER

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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