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FDA 510(k)

NUMED BALLOON THERMODILUTION CATHETER

K-Number: K881893 · 1988-09-06

ApplicantNuMED, Inc.
Decision Date1988-09-06
Product CodeKRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NUMED BALLOON THERMODILUTION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is NuMED, Inc.. It received FDA 510(k) clearance on 1988-09-06 under 510(k) number K881893. 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 NUMED BALLOON THERMODILUTION CATHETER?

NUMED BALLOON THERMODILUTION CATHETER is a medical device that received FDA 510(k) clearance on 1988-09-06. The listed applicant is NuMED, Inc.. The 510(k) number is K881893.

When did NUMED BALLOON THERMODILUTION CATHETER receive FDA 510(k) clearance?

NUMED BALLOON THERMODILUTION CATHETER received FDA 510(k) clearance on 1988-09-06, under 510(k) number K881893.

Who is the listed applicant for NUMED BALLOON THERMODILUTION CATHETER?

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

What is the FDA product code for NUMED BALLOON THERMODILUTION CATHETER?

The FDA product code for NUMED BALLOON THERMODILUTION CATHETER 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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