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FDA 510(k)

DURASPAN HEMODIALYSIS LONG-TERM CATHETER

K-Number: K100169 · 2010-02-18

ApplicantR4 Vascular, Inc.
Decision Date2010-02-18
Product CodeMSD
Advisory CommitteeGU
DecisionUnknown

Device Summary

DURASPAN HEMODIALYSIS LONG-TERM CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is R4 Vascular, Inc.. It received FDA 510(k) clearance on 2010-02-18 under 510(k) number K100169. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the DURASPAN HEMODIALYSIS LONG-TERM CATHETER?

DURASPAN HEMODIALYSIS LONG-TERM CATHETER is a medical device that received FDA 510(k) clearance on 2010-02-18. The listed applicant is R4 Vascular, Inc.. The 510(k) number is K100169.

When did DURASPAN HEMODIALYSIS LONG-TERM CATHETER receive FDA 510(k) clearance?

DURASPAN HEMODIALYSIS LONG-TERM CATHETER received FDA 510(k) clearance on 2010-02-18, under 510(k) number K100169.

Who is the listed applicant for DURASPAN HEMODIALYSIS LONG-TERM CATHETER?

The FDA 510(k) record lists R4 Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DURASPAN HEMODIALYSIS LONG-TERM CATHETER?

The FDA product code for DURASPAN HEMODIALYSIS LONG-TERM CATHETER is MSD.

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Other records listing R4 Vascular, 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.

K131329VECTOR PTA BALLOON DILATATION CATHETERK121385VECTORK091506DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520K092040PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240K083763ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMENK071361R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005

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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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