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FDA 510(k)

DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)

K-Number: K010399 · 2001-08-14

ApplicantDiatek, Inc.
Decision Date2001-08-14
Product CodeMSD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM) is the device name listed in this FDA 510(k) record. The listed applicant is Diatek, Inc.. It received FDA 510(k) clearance on 2001-08-14 under 510(k) number K010399. 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 DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)?

DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM) is a medical device that received FDA 510(k) clearance on 2001-08-14. The listed applicant is Diatek, Inc.. The 510(k) number is K010399.

When did DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM) receive FDA 510(k) clearance?

DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM) received FDA 510(k) clearance on 2001-08-14, under 510(k) number K010399.

Who is the listed applicant for DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)?

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

What is the FDA product code for DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)?

The FDA product code for DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM) is MSD.

Related Clinical Trials

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.

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Other records listing Diatek, 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.

K020430DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)K895703DIATEK MODEL 700 THERMOMETERK872178MODIFICATION TO ARKIVE(TM)K862085ARKIVE (TM)K841827ENTEROPORT NUTRITION PUMPK841859SECURA SET

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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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