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FDA 510(k)

BENTLEY THEROMODILUTION CATHETER #BTD-7F

K-Number: K802133 · 1980-09-26

ApplicantBentley Laboratories, Inc.
Decision Date1980-09-26
Product CodeKRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BENTLEY THEROMODILUTION CATHETER #BTD-7F is the device name listed in this FDA 510(k) record. The listed applicant is Bentley Laboratories, Inc.. It received FDA 510(k) clearance on 1980-09-26 under 510(k) number K802133. 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 BENTLEY THEROMODILUTION CATHETER #BTD-7F?

BENTLEY THEROMODILUTION CATHETER #BTD-7F is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is Bentley Laboratories, Inc.. The 510(k) number is K802133.

When did BENTLEY THEROMODILUTION CATHETER #BTD-7F receive FDA 510(k) clearance?

BENTLEY THEROMODILUTION CATHETER #BTD-7F received FDA 510(k) clearance on 1980-09-26, under 510(k) number K802133.

Who is the listed applicant for BENTLEY THEROMODILUTION CATHETER #BTD-7F?

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

What is the FDA product code for BENTLEY THEROMODILUTION CATHETER #BTD-7F?

The FDA product code for BENTLEY THEROMODILUTION CATHETER #BTD-7F is KRB.

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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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