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FDA 510(k)

PBN GUIDEWIRES

K-Number: K031442 · 2003-08-13

ApplicantMedical Device Technologies, Inc.
Decision Date2003-08-13
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PBN GUIDEWIRES is the device name listed in this FDA 510(k) record. The listed applicant is Medical Device Technologies, Inc.. It received FDA 510(k) clearance on 2003-08-13 under 510(k) number K031442. 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 PBN GUIDEWIRES?

PBN GUIDEWIRES is a medical device that received FDA 510(k) clearance on 2003-08-13. The listed applicant is Medical Device Technologies, Inc.. The 510(k) number is K031442.

When did PBN GUIDEWIRES receive FDA 510(k) clearance?

PBN GUIDEWIRES received FDA 510(k) clearance on 2003-08-13, under 510(k) number K031442.

Who is the listed applicant for PBN GUIDEWIRES?

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

What is the FDA product code for PBN GUIDEWIRES?

The FDA product code for PBN GUIDEWIRES is DQX.

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Other records listing Medical Device Technologies, 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.

K101832BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENTK053518INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHORK051421INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHORK050873CANALIZER HYDROPHILIC GUIDE WIREK043523INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLEK042464V-CORE FULL CORE BREAST BIOPSY INSTRUMENT

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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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