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FDA 510(k)

SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIES

K-Number: K934122 · 1993-10-07

ApplicantScimed Peripheral Interventions
Decision Date1993-10-07
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Scimed Peripheral Interventions. It received FDA 510(k) clearance on 1993-10-07 under 510(k) number K934122. 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 TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIES?

SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1993-10-07. The listed applicant is Scimed Peripheral Interventions. The 510(k) number is K934122.

When did SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIES receive FDA 510(k) clearance?

SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIES received FDA 510(k) clearance on 1993-10-07, under 510(k) number K934122.

Who is the listed applicant for SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIES?

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

What is the FDA product code for SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIES?

The FDA product code for SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIES is DQX.

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Other records listing Scimed Peripheral Interventions 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.

K945904SCIMED(R) VENTURE(TM) II INFUSION CATHETERK946272SCIMED(R) COURIER GUIDE CATHETERK944677SCIMED TRANSENT EX STEERABLE GUIDE WIRE AND ACCESSORIESK941710SCIMED TRANSEND STEERABLE GUIDE WIRE AND ACCESSORIESK935501SCIMED VIPER PTA CATHETER WITH BIOSLIDE HYDROPHILIC COATINGK934793SCIMED MAVERICK

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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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