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FDA 510(k)

MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY

K-Number: K982333 · 1999-02-12

ApplicantCook, Inc.
Decision Date1999-02-12
Product CodeMSD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 1999-02-12 under 510(k) number K982333. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY?

MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY is a medical device that received FDA 510(k) clearance on 1999-02-12. The listed applicant is Cook, Inc.. The 510(k) number is K982333.

When did MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY receive FDA 510(k) clearance?

MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY received FDA 510(k) clearance on 1999-02-12, under 510(k) number K982333.

Who is the listed applicant for MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY?

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 MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY?

The FDA product code for MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY is MSD.

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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: MSD)

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.

K241581Hemodialysis CatheterHaolang Medical USA CorporationK210461End CapMedical Components Inc (Medcomp)K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc.K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc.K203767Pristine Long-Term Hemodialysis CatheterC B Bard, Inc.K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc.

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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