Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Spartan Center Wire

K-Number: K220075 · 2022-04-19

ApplicantSpartan Micro, Inc.
Decision Date2022-04-19
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Spartan Center Wire is the device name listed in this FDA 510(k) record. The listed applicant is Spartan Micro, Inc.. It received FDA 510(k) clearance on 2022-04-19 under 510(k) number K220075. 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 Spartan Center Wire?

Spartan Center Wire is a medical device that received FDA 510(k) clearance on 2022-04-19. The listed applicant is Spartan Micro, Inc.. The 510(k) number is K220075.

When did Spartan Center Wire receive FDA 510(k) clearance?

Spartan Center Wire received FDA 510(k) clearance on 2022-04-19, under 510(k) number K220075.

Who is the listed applicant for Spartan Center Wire?

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

What is the FDA product code for Spartan Center Wire?

The FDA product code for Spartan Center Wire is DQX.

Other records listing Spartan Micro, 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.

K220716Spartan SC 069K213451Spartan MC 0165K180653Spartan eCoil System

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.

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.K253746Enroute 0.014'' Transcarotid GuidewireLake Region MedicalK253262EmeryGlide™ (EG18008901)Nano4imaging GmbH

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.

↑