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FDA 510(k)

INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER

K-Number: K900710 · 1990-10-19

ApplicantIntec Medical, Inc.
Decision Date1990-10-19
Product CodeKRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Intec Medical, Inc.. It received FDA 510(k) clearance on 1990-10-19 under 510(k) number K900710. The device is classified under product code KRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER?

INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER is a medical device that received FDA 510(k) clearance on 1990-10-19. The listed applicant is Intec Medical, Inc.. The 510(k) number is K900710.

When did INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER receive FDA 510(k) clearance?

INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER received FDA 510(k) clearance on 1990-10-19, under 510(k) number K900710.

Who is the listed applicant for INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER?

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

What is the FDA product code for INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER?

The FDA product code for INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER is KRB.

Related Clinical Trials

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Other records listing Intec Medical, 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.

K911840INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETERK903216THE GUIDER CORONARY GUIDING CATHETERK903217TAPERED TIP THE GUIDER CORONARY GUIDING CATHETERK903840GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSYK903906PERCUTANEOUS CATHETER INTRODUCER KITK900998INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE

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Related Devices (Code: KRB)

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.

K171620PiCCO CatheterPulsion Medical Systems SEK100739VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5Edwards Lifesciences, LLCK072364PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIESPulsion Medical Systems AGK020587PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046Pulsion Medical Systems AGK991886PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSORPulsion Medical Systems, Inc.K936182CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KITOhmeda Medical

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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