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FDA 510(k)

SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX

K-Number: K061171 · 2006-06-02

ApplicantBiosphere Medical, Inc.
Decision Date2006-06-02
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX is the device name listed in this FDA 510(k) record. The listed applicant is Biosphere Medical, Inc.. It received FDA 510(k) clearance on 2006-06-02 under 510(k) number K061171. 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 SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX?

SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX is a medical device that received FDA 510(k) clearance on 2006-06-02. The listed applicant is Biosphere Medical, Inc.. The 510(k) number is K061171.

When did SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX receive FDA 510(k) clearance?

SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX received FDA 510(k) clearance on 2006-06-02, under 510(k) number K061171.

Who is the listed applicant for SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX?

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

What is the FDA product code for SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX?

The FDA product code for SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX is DQX.

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Other records listing Biosphere 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.

K113822QUADRASPHERE 30 TO 60K052742HEPASPHERE MICROSPHERESK062126EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135K021397EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATIONK010026EMBOGOLD MICROSPHERE

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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