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FDA 510(k)

FLOW-DIRECTED PEDIATRIC THERMODIL- CATH

K-Number: K843410 · 1984-11-20

ApplicantAndover Medical, Inc.
Decision Date1984-11-20
Product CodeKRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLOW-DIRECTED PEDIATRIC THERMODIL- CATH is the device name listed in this FDA 510(k) record. The listed applicant is Andover Medical, Inc.. It received FDA 510(k) clearance on 1984-11-20 under 510(k) number K843410. 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 FLOW-DIRECTED PEDIATRIC THERMODIL- CATH?

FLOW-DIRECTED PEDIATRIC THERMODIL- CATH is a medical device that received FDA 510(k) clearance on 1984-11-20. The listed applicant is Andover Medical, Inc.. The 510(k) number is K843410.

When did FLOW-DIRECTED PEDIATRIC THERMODIL- CATH receive FDA 510(k) clearance?

FLOW-DIRECTED PEDIATRIC THERMODIL- CATH received FDA 510(k) clearance on 1984-11-20, under 510(k) number K843410.

Who is the listed applicant for FLOW-DIRECTED PEDIATRIC THERMODIL- CATH?

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

What is the FDA product code for FLOW-DIRECTED PEDIATRIC THERMODIL- CATH?

The FDA product code for FLOW-DIRECTED PEDIATRIC THERMODIL- CATH 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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