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FDA 510(k)

CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)

K-Number: K121398 · 2012-12-13

ApplicantGuidepath Medical, Inc.
Decision Date2012-12-13
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF) is the device name listed in this FDA 510(k) record. The listed applicant is Guidepath Medical, Inc.. It received FDA 510(k) clearance on 2012-12-13 under 510(k) number K121398. 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 CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)?

CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF) is a medical device that received FDA 510(k) clearance on 2012-12-13. The listed applicant is Guidepath Medical, Inc.. The 510(k) number is K121398.

When did CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF) receive FDA 510(k) clearance?

CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF) received FDA 510(k) clearance on 2012-12-13, under 510(k) number K121398.

Who is the listed applicant for CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)?

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

What is the FDA product code for CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)?

The FDA product code for CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF) is DQX.

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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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