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FDA 510(k)

FLOW-DIRECTED BALLOON THERMODILUTION

K-Number: K812761 · 1981-11-02

ApplicantNova Medical Specialties
Decision Date1981-11-02
Product CodeKRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLOW-DIRECTED BALLOON THERMODILUTION is the device name listed in this FDA 510(k) record. The listed applicant is Nova Medical Specialties. It received FDA 510(k) clearance on 1981-11-02 under 510(k) number K812761. The device is classified under product code KRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOW-DIRECTED BALLOON THERMODILUTION?

FLOW-DIRECTED BALLOON THERMODILUTION is a medical device that received FDA 510(k) clearance on 1981-11-02. The listed applicant is Nova Medical Specialties. The 510(k) number is K812761.

When did FLOW-DIRECTED BALLOON THERMODILUTION receive FDA 510(k) clearance?

FLOW-DIRECTED BALLOON THERMODILUTION received FDA 510(k) clearance on 1981-11-02, under 510(k) number K812761.

Who is the listed applicant for FLOW-DIRECTED BALLOON THERMODILUTION?

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

What is the FDA product code for FLOW-DIRECTED BALLOON THERMODILUTION?

The FDA product code for FLOW-DIRECTED BALLOON THERMODILUTION is KRG.

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Other records listing Nova Medical Specialties 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.

K872770DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH.K860526NOVA BALLOON THERMODILUTION PRESSURE TRANS CATHK853625NOVA ARTERIAL EMBOLECTOMY CATHETERK840009NOVA 12 CARDIAC OUTPUT COMPUTERK841640NOVA BALLOON THERMODILUTION INFUSIONK841639NOVA BALLOON THERMODILUTION CATH.

View all 11 devices →

Related Devices (Code: KRG)

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.

K933278INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04Intermedics, Inc.K884522MODEL 5650 OPTIMATE PERSONAL PROGRAMMERTeletronics, Inc.K880738MODEL 2331T PATIENT PROGRAMMERMedtronic VascularK882429MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004Tpl-Cordis, Inc.K864712MODEL 1740 PERSONAL POCKET PROGRAMMERTelectronics, Inc.K871986MODEL 5600B PROGRAMMER, PACEMAKERTelectronics, 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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