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FDA 510(k)

PLATINUM PLUS GUIDEWIRE

K-Number: K935997 · 1994-06-17

ApplicantBoston Scientific Corp
Decision Date1994-06-17
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PLATINUM PLUS GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1994-06-17 under 510(k) number K935997. 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 PLATINUM PLUS GUIDEWIRE?

PLATINUM PLUS GUIDEWIRE is a medical device that received FDA 510(k) clearance on 1994-06-17. The listed applicant is Boston Scientific Corp. The 510(k) number is K935997.

When did PLATINUM PLUS GUIDEWIRE receive FDA 510(k) clearance?

PLATINUM PLUS GUIDEWIRE received FDA 510(k) clearance on 1994-06-17, under 510(k) number K935997.

Who is the listed applicant for PLATINUM PLUS GUIDEWIRE?

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

What is the FDA product code for PLATINUM PLUS GUIDEWIRE?

The FDA product code for PLATINUM PLUS GUIDEWIRE is DQX.

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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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