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FDA 510(k)

Pre-Formed Blue

K-Number: K221575 · 2022-10-07

ApplicantLake Region Medical
Decision Date2022-10-07
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pre-Formed Blue is the device name listed in this FDA 510(k) record. The listed applicant is Lake Region Medical. It received FDA 510(k) clearance on 2022-10-07 under 510(k) number K221575. 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 Pre-Formed Blue?

Pre-Formed Blue is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is Lake Region Medical. The 510(k) number is K221575.

When did Pre-Formed Blue receive FDA 510(k) clearance?

Pre-Formed Blue received FDA 510(k) clearance on 2022-10-07, under 510(k) number K221575.

Who is the listed applicant for Pre-Formed Blue?

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

What is the FDA product code for Pre-Formed Blue?

The FDA product code for Pre-Formed Blue is DQX.

Other records listing Lake Region Medical 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.

K253746Enroute 0.014'' Transcarotid GuidewireK242824PTFE GuidewireK211741Pre-Formed Extra Support GuidewireK160643ENROUTE 0.014 Guidewire

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.

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