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FDA 510(k)

CARDIA-CATH

K-Number: K112323 · 2011-10-18

ApplicantMillar Instruments, Inc.
Decision Date2011-10-18
Product CodeDXO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIA-CATH 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 2011-10-18 under 510(k) number K112323. The device is classified under product code DXO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIA-CATH?

CARDIA-CATH is a medical device that received FDA 510(k) clearance on 2011-10-18. The listed applicant is Millar Instruments, Inc.. The 510(k) number is K112323.

When did CARDIA-CATH receive FDA 510(k) clearance?

CARDIA-CATH received FDA 510(k) clearance on 2011-10-18, under 510(k) number K112323.

Who is the listed applicant for CARDIA-CATH?

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 CARDIA-CATH?

The FDA product code for CARDIA-CATH is DXO.

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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.

K093111MIKRO-CATH, MODEL 825-0101K013205MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000K993694MIKRO-TIP ANGIOGRAPHIC CATHETERK952773MIKRO-TIP ANGIOGRAPHIC CATHETERK935166FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCERK915775MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN

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Related Devices (Code: DXO)

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.

K251367OptoMonitor 3Opsens, Inc.K241418OptoMonitor 3Opsens, Inc.K233904ACIST RXi System (016616); ACIST Navvus II Catheter (016675_Acist Medical Systems, Inc.K222216TruWave Disposable Pressure TransducerEdwards Lifesciences, LLCK202943OptoMonitor 3Opsens, Inc.K193620OptoMonitor 3Opsens, 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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