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FDA 510(k)

MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000

K-Number: K013205 · 2002-07-02

ApplicantMillar Instruments, Inc.
Decision Date2002-07-02
Product CodeDRQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Millar Instruments, Inc.. It received FDA 510(k) clearance on 2002-07-02 under 510(k) number K013205. The device is classified under product code DRQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000?

MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 is a medical device that received FDA 510(k) clearance on 2002-07-02. The listed applicant is Millar Instruments, Inc.. The 510(k) number is K013205.

When did MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 receive FDA 510(k) clearance?

MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 received FDA 510(k) clearance on 2002-07-02, under 510(k) number K013205.

Who is the listed applicant for MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000?

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

What is the FDA product code for MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000?

The FDA product code for MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 is DRQ.

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Other records listing Millar Instruments, 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.

K112323CARDIA-CATHK093111MIKRO-CATH, MODEL 825-0101K993694MIKRO-TIP ANGIOGRAPHIC CATHETERK952773MIKRO-TIP ANGIOGRAPHIC CATHETERK935166FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCERK915775MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN

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Related Devices (Code: DRQ)

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.

K172216ACIST RXi Mini SystemAcist Medical Systems, Inc.K050006BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIOC.R. Bard, Inc.K050974DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERSDraeger Medical Systems, Inc.K033807INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTERDraeger Medical Systems, Inc.K020277SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTERSiemens Medical Solutions USA, Inc.K010640SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTERSiemens Medical Solutions USA, 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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