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FDA 510(k)

ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER

K-Number: K102043 · 2010-11-18

ApplicantRex Medical
Decision Date2010-11-18
Product CodeMSD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Rex Medical. It received FDA 510(k) clearance on 2010-11-18 under 510(k) number K102043. 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 ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER?

ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER is a medical device that received FDA 510(k) clearance on 2010-11-18. The listed applicant is Rex Medical. The 510(k) number is K102043.

When did ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER receive FDA 510(k) clearance?

ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER received FDA 510(k) clearance on 2010-11-18, under 510(k) number K102043.

Who is the listed applicant for ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER?

The FDA 510(k) record lists Rex Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER?

The FDA product code for ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER is MSD.

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Other records listing Rex Medical 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.

K120346CLEANER ROTATIONAL THROMBECTOMY SYSTEMK113103SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICEK091029CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM)K081410OPTION VENA CAVA FILTERK07142215.5F HEMO-STREAM HEMODIALYSIS CATHETER SETK051468INNER-LOCK INTRODUCER SHEATH

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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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