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FDA 510(k)

RAILWIRE

K-Number: K954552 · 1996-04-29

ApplicantBoston Scientific /International Technologies
Decision Date1996-04-29
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RAILWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific /International Technologies. It received FDA 510(k) clearance on 1996-04-29 under 510(k) number K954552. 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 RAILWIRE?

RAILWIRE is a medical device that received FDA 510(k) clearance on 1996-04-29. The listed applicant is Boston Scientific /International Technologies. The 510(k) number is K954552.

When did RAILWIRE receive FDA 510(k) clearance?

RAILWIRE received FDA 510(k) clearance on 1996-04-29, under 510(k) number K954552.

Who is the listed applicant for RAILWIRE?

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

What is the FDA product code for RAILWIRE?

The FDA product code for RAILWIRE 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 /International Technologies 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.

K971688IVT 0.014 PTFE-COATED TRACKWIREK96366311F GUIDING CATHETERK954622IVT 0.014 TRACK OR IVT 0.014 ACCUTRACKK930808PROTECTOR INTRODUCER SHEATH

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

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

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