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FDA 510(k)

PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH.

K-Number: K894747 · 1989-10-12

ApplicantEndosonics Corp.
Decision Date1989-10-12
Product CodeDXO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH. is the device name listed in this FDA 510(k) record. The listed applicant is Endosonics Corp.. It received FDA 510(k) clearance on 1989-10-12 under 510(k) number K894747. 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 PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH.?

PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH. is a medical device that received FDA 510(k) clearance on 1989-10-12. The listed applicant is Endosonics Corp.. The 510(k) number is K894747.

When did PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH. receive FDA 510(k) clearance?

PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH. received FDA 510(k) clearance on 1989-10-12, under 510(k) number K894747.

Who is the listed applicant for PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH.?

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

What is the FDA product code for PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH.?

The FDA product code for PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH. is DXO.

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Other records listing Endosonics Corp. as applicant

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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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