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FDA 510(k)

MIRAFLEX HIGH FLOW MICROCATHETER

K-Number: K080737 · 2008-08-08

ApplicantCook, Inc.
Decision Date2008-08-08
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MIRAFLEX HIGH FLOW MICROCATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 2008-08-08 under 510(k) number K080737. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIRAFLEX HIGH FLOW MICROCATHETER?

MIRAFLEX HIGH FLOW MICROCATHETER is a medical device that received FDA 510(k) clearance on 2008-08-08. The listed applicant is Cook, Inc.. The 510(k) number is K080737.

When did MIRAFLEX HIGH FLOW MICROCATHETER receive FDA 510(k) clearance?

MIRAFLEX HIGH FLOW MICROCATHETER received FDA 510(k) clearance on 2008-08-08, under 510(k) number K080737.

Who is the listed applicant for MIRAFLEX HIGH FLOW MICROCATHETER?

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

What is the FDA product code for MIRAFLEX HIGH FLOW MICROCATHETER?

The FDA product code for MIRAFLEX HIGH FLOW MICROCATHETER is KRA.

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Other records listing Cook, Inc. as applicant

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K133634SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SETK132020ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETERK131201ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SETK131206COOK CERVICAL RIPENING BALLOONK132334TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SETK122091COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY

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Related Devices (Code: KRA)

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.

K253509TriSalus TriNav Advance Infusion SystemTrisalus Life SciencesK254051Extroducer Infusion Catheter SystemSmartWise Sweden ABK261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific CorporationK250794InVera Infusion DeviceInvera MedicalK243534Micro CatheterSuzhou Zenith Vascular SciTech Limited

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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