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FDA 510(k)

ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY

K-Number: K913468 · 1994-03-24

ApplicantCook, Inc.
Decision Date1994-03-24
Product CodeLFJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/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 1994-03-24 under 510(k) number K913468. The device is classified under product code LFJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY?

ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY is a medical device that received FDA 510(k) clearance on 1994-03-24. The listed applicant is Cook, Inc.. The 510(k) number is K913468.

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

ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY received FDA 510(k) clearance on 1994-03-24, under 510(k) number K913468.

Who is the listed applicant for ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/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 ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY?

The FDA product code for ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY is LFJ.

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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: LFJ)

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.

K920780MEDSURG INSERTION TRAYMedsurg Industries, Inc.K925819AKCESS0CATH KITAkcess Medical Products, Inc.K925818AKCESS-CATHAkcess Medical Products, Inc.K931120COAXIAL ACUTE CATHETERAkcess Medical Products, Inc.K920634SPLITTABLE SHEATH INTRODUCER SETAkcess Medical Products, Inc.K914162VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERSVas-Cath, 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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