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FDA 510(k)

MEDRAD OPEN ENDED GUIDEWIRE

K-Number: K880332 · 1988-07-28

ApplicantMedrad, Inc.
Decision Date1988-07-28
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDRAD OPEN ENDED GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Medrad, Inc.. It received FDA 510(k) clearance on 1988-07-28 under 510(k) number K880332. 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 MEDRAD OPEN ENDED GUIDEWIRE?

MEDRAD OPEN ENDED GUIDEWIRE is a medical device that received FDA 510(k) clearance on 1988-07-28. The listed applicant is Medrad, Inc.. The 510(k) number is K880332.

When did MEDRAD OPEN ENDED GUIDEWIRE receive FDA 510(k) clearance?

MEDRAD OPEN ENDED GUIDEWIRE received FDA 510(k) clearance on 1988-07-28, under 510(k) number K880332.

Who is the listed applicant for MEDRAD OPEN ENDED GUIDEWIRE?

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

What is the FDA product code for MEDRAD OPEN ENDED GUIDEWIRE?

The FDA product code for MEDRAD OPEN ENDED GUIDEWIRE is DQX.

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Other records listing Medrad, Inc. as applicant

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K130381ANGIOJET ULTRA POWER PULSE KITK130637JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEMK122916JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEMK113363ANGIOJET SOLENT DISTA THROMBECTOMY SETK113133MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGEK113428ANGIOJET ULTRA DVX THROMBECTOMY SET

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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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