FDA 510(k)

SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING

K-Number: K033843 · 2004-08-12

Decision Date2004-08-12

Product CodeFOZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 2004-08-12 under 510(k) number K033843. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING?

SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING is a medical device that received FDA 510(k) clearance on 2004-08-12. The listed applicant is Cook, Inc.. The 510(k) number is K033843.

When did SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING receive FDA 510(k) clearance?

SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING received FDA 510(k) clearance on 2004-08-12, under 510(k) number K033843.

Who is the listed applicant for SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING?

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 SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING?

The FDA product code for SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING is FOZ.

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Other records listing Cook, Inc. as applicant

K133634SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET K132020ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER K131201ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET K131206COOK CERVICAL RIPENING BALLOON K132334TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET K122091COOK 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: FOZ)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.