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FDA 510(k)

APPROACH HYDRO ST WIRE GUIDE, MODEL HMW

K-Number: K091385 · 2009-08-07

ApplicantCook, Inc.
Decision Date2009-08-07
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

APPROACH HYDRO ST WIRE GUIDE, MODEL HMW is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 2009-08-07 under 510(k) number K091385. 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 APPROACH HYDRO ST WIRE GUIDE, MODEL HMW?

APPROACH HYDRO ST WIRE GUIDE, MODEL HMW is a medical device that received FDA 510(k) clearance on 2009-08-07. The listed applicant is Cook, Inc.. The 510(k) number is K091385.

When did APPROACH HYDRO ST WIRE GUIDE, MODEL HMW receive FDA 510(k) clearance?

APPROACH HYDRO ST WIRE GUIDE, MODEL HMW received FDA 510(k) clearance on 2009-08-07, under 510(k) number K091385.

Who is the listed applicant for APPROACH HYDRO ST WIRE GUIDE, MODEL HMW?

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 APPROACH HYDRO ST WIRE GUIDE, MODEL HMW?

The FDA product code for APPROACH HYDRO ST WIRE GUIDE, MODEL HMW is DQX.

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Other records listing Cook, 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.

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: 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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