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FDA 510(k)

MODIFICATIONS TO SERIES OF CARDIAC CATHETERS

K-Number: K913042 · 1992-10-21

ApplicantSentron, Inc.
Decision Date1992-10-21
Product CodeDXO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATIONS TO SERIES OF CARDIAC CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Sentron, Inc.. It received FDA 510(k) clearance on 1992-10-21 under 510(k) number K913042. 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 MODIFICATIONS TO SERIES OF CARDIAC CATHETERS?

MODIFICATIONS TO SERIES OF CARDIAC CATHETERS is a medical device that received FDA 510(k) clearance on 1992-10-21. The listed applicant is Sentron, Inc.. The 510(k) number is K913042.

When did MODIFICATIONS TO SERIES OF CARDIAC CATHETERS receive FDA 510(k) clearance?

MODIFICATIONS TO SERIES OF CARDIAC CATHETERS received FDA 510(k) clearance on 1992-10-21, under 510(k) number K913042.

Who is the listed applicant for MODIFICATIONS TO SERIES OF CARDIAC CATHETERS?

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

What is the FDA product code for MODIFICATIONS TO SERIES OF CARDIAC CATHETERS?

The FDA product code for MODIFICATIONS TO SERIES OF CARDIAC CATHETERS 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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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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