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FDA 510(k)

DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)

K-Number: K020430 · 2002-05-09

ApplicantDiatek, Inc.
Decision Date2002-05-09
Product CodeNFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) is the device name listed in this FDA 510(k) record. The listed applicant is Diatek, Inc.. It received FDA 510(k) clearance on 2002-05-09 under 510(k) number K020430. The device is classified under product code NFK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)?

DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) is a medical device that received FDA 510(k) clearance on 2002-05-09. The listed applicant is Diatek, Inc.. The 510(k) number is K020430.

When did DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) receive FDA 510(k) clearance?

DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) received FDA 510(k) clearance on 2002-05-09, under 510(k) number K020430.

Who is the listed applicant for DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)?

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 CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)?

The FDA product code for DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) is NFK.

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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.

K010399DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)K895703DIATEK MODEL 700 THERMOMETERK872178MODIFICATION TO ARKIVE(TM)K862085ARKIVE (TM)K841827ENTEROPORT NUTRITION PUMPK841859SECURA SET

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Related Devices (Code: NFK)

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.

K101261CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000C.R. Bard, Inc.K092797ACUTE AND CHRONIC CATHETER REPAIR KITKendallK063446CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000C.R. Bard, Inc.K062435REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERSSpire Biomedical, Inc.K030442CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000C.R. Bard, Inc.K022644RETRO REPAIR KIT, MODEL PRRK5Spire Biomedical, 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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