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FDA 510(k)

PRESSURE WIRE SENSOR, MODELS 12004/12304

K-Number: K031662 · 2003-06-06

ApplicantRadi Medical Systems AB
Decision Date2003-06-06
Product CodeDXO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRESSURE WIRE SENSOR, MODELS 12004/12304 is the device name listed in this FDA 510(k) record. The listed applicant is Radi Medical Systems AB. It received FDA 510(k) clearance on 2003-06-06 under 510(k) number K031662. 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 PRESSURE WIRE SENSOR, MODELS 12004/12304?

PRESSURE WIRE SENSOR, MODELS 12004/12304 is a medical device that received FDA 510(k) clearance on 2003-06-06. The listed applicant is Radi Medical Systems AB. The 510(k) number is K031662.

When did PRESSURE WIRE SENSOR, MODELS 12004/12304 receive FDA 510(k) clearance?

PRESSURE WIRE SENSOR, MODELS 12004/12304 received FDA 510(k) clearance on 2003-06-06, under 510(k) number K031662.

Who is the listed applicant for PRESSURE WIRE SENSOR, MODELS 12004/12304?

The FDA 510(k) record lists Radi Medical Systems AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRESSURE WIRE SENSOR, MODELS 12004/12304?

The FDA product code for PRESSURE WIRE SENSOR, MODELS 12004/12304 is DXO.

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 Radi Medical Systems AB 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.

K123984QUANTIEN MEASUREMENT SYSTEMK092105RADIANALYZER XPRESSK080813PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVERK080206MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEMK062769PRESSUREWIRE CERTUS, MODELS 12006 AND 12306K042628MODIFICATION TO: RADIANALYZER, MODEL 12711

View all 24 devices →

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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