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FDA 510(k)

MODEL SP5107 THERMODILUTION CATHETER

K-Number: K810730 · 1981-03-27

ApplicantGould, Inc.
Decision Date1981-03-27
Product CodeKRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL SP5107 THERMODILUTION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Gould, Inc.. It received FDA 510(k) clearance on 1981-03-27 under 510(k) number K810730. 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 MODEL SP5107 THERMODILUTION CATHETER?

MODEL SP5107 THERMODILUTION CATHETER is a medical device that received FDA 510(k) clearance on 1981-03-27. The listed applicant is Gould, Inc.. The 510(k) number is K810730.

When did MODEL SP5107 THERMODILUTION CATHETER receive FDA 510(k) clearance?

MODEL SP5107 THERMODILUTION CATHETER received FDA 510(k) clearance on 1981-03-27, under 510(k) number K810730.

Who is the listed applicant for MODEL SP5107 THERMODILUTION CATHETER?

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

What is the FDA product code for MODEL SP5107 THERMODILUTION CATHETER?

The FDA product code for MODEL SP5107 THERMODILUTION CATHETER is KRB.

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Other records listing Gould, 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.

K911935CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIEDK861092MODEL SP1465 CARDIAC OUTPUT COMPUTERK860805PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337K855145MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATORK854403MODEL 2120 SPIROSCREENK851486GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX

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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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