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FDA 510(k)

BURRON TEFLON-COATED GUIDEWIRE

K-Number: K884183 · 1989-08-03

ApplicantBurron Medical, Inc.
Decision Date1989-08-03
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BURRON TEFLON-COATED GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Burron Medical, Inc.. It received FDA 510(k) clearance on 1989-08-03 under 510(k) number K884183. 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 BURRON TEFLON-COATED GUIDEWIRE?

BURRON TEFLON-COATED GUIDEWIRE is a medical device that received FDA 510(k) clearance on 1989-08-03. The listed applicant is Burron Medical, Inc.. The 510(k) number is K884183.

When did BURRON TEFLON-COATED GUIDEWIRE receive FDA 510(k) clearance?

BURRON TEFLON-COATED GUIDEWIRE received FDA 510(k) clearance on 1989-08-03, under 510(k) number K884183.

Who is the listed applicant for BURRON TEFLON-COATED GUIDEWIRE?

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

What is the FDA product code for BURRON TEFLON-COATED GUIDEWIRE?

The FDA product code for BURRON TEFLON-COATED GUIDEWIRE is DQX.

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Other records listing Burron Medical, Inc. 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.

K902401CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEMK896422BURRON AMBULATORY DRUG DELIVERY SYSTEMK884235COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KITK895191ANTI-THROMBOGENIC COATING FOR CATHETERSK895192SPINOCAN(R) CONTINUOUS SPINAL TRAYK882106PERFUSOR M SYRINGE PUMP

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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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