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FDA 510(k)

MIRA-FLEX 18 MICROCATHETER

K-Number: K052841 · 2005-12-08

ApplicantCook, Inc.
Decision Date2005-12-08
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MIRA-FLEX 18 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 2005-12-08 under 510(k) number K052841. 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 MIRA-FLEX 18 MICROCATHETER?

MIRA-FLEX 18 MICROCATHETER is a medical device that received FDA 510(k) clearance on 2005-12-08. The listed applicant is Cook, Inc.. The 510(k) number is K052841.

When did MIRA-FLEX 18 MICROCATHETER receive FDA 510(k) clearance?

MIRA-FLEX 18 MICROCATHETER received FDA 510(k) clearance on 2005-12-08, under 510(k) number K052841.

Who is the listed applicant for MIRA-FLEX 18 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 MIRA-FLEX 18 MICROCATHETER?

The FDA product code for MIRA-FLEX 18 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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