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FDA 510(k)

SCIMED SIDELINER

K-Number: K922706 · 1992-12-10

ApplicantScimed
Decision Date1992-12-10
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCIMED SIDELINER is the device name listed in this FDA 510(k) record. The listed applicant is Scimed. It received FDA 510(k) clearance on 1992-12-10 under 510(k) number K922706. 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 SCIMED SIDELINER?

SCIMED SIDELINER is a medical device that received FDA 510(k) clearance on 1992-12-10. The listed applicant is Scimed. The 510(k) number is K922706.

When did SCIMED SIDELINER receive FDA 510(k) clearance?

SCIMED SIDELINER received FDA 510(k) clearance on 1992-12-10, under 510(k) number K922706.

Who is the listed applicant for SCIMED SIDELINER?

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

What is the FDA product code for SCIMED SIDELINER?

The FDA product code for SCIMED SIDELINER is DQX.

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Other records listing Scimed 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.

K992142SCIMED ANGIOGRAPHIC CATHETERSK953909SCIMED 6 FRENCH MICRO-MAX GUIDE CATHETERK931584SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS.K915347SCIMED VIPER CATHETERK9109877FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVEK904171SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM

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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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