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FDA 510(k)

SELECTIVA SB GUIDEWIRE

K-Number: K033321 · 2003-11-05

ApplicantNeometrics, Inc.
Decision Date2003-11-05
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SELECTIVA SB GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Neometrics, Inc.. It received FDA 510(k) clearance on 2003-11-05 under 510(k) number K033321. 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 SELECTIVA SB GUIDEWIRE?

SELECTIVA SB GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2003-11-05. The listed applicant is Neometrics, Inc.. The 510(k) number is K033321.

When did SELECTIVA SB GUIDEWIRE receive FDA 510(k) clearance?

SELECTIVA SB GUIDEWIRE received FDA 510(k) clearance on 2003-11-05, under 510(k) number K033321.

Who is the listed applicant for SELECTIVA SB GUIDEWIRE?

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

What is the FDA product code for SELECTIVA SB GUIDEWIRE?

The FDA product code for SELECTIVA SB GUIDEWIRE is DQX.

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Other records listing Neometrics, 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.

K123439NEO ERCP GUIDEWIREK101729NEOWIRE PTA/PTCA GUIDEWIREK070150VASCUPUNCTURE PICC GUIDEWIREK043398MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIREK040786VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATINGK031652VASCUPUNCTURE PICC GUIDEWIRE

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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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