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FDA 510(k)

THERMODILUTION CATHETER INTRO. KIT

K-Number: K800619 · 1980-04-24

ApplicantNorton Performance Plastics Corp.
Decision Date1980-04-24
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THERMODILUTION CATHETER INTRO. KIT is the device name listed in this FDA 510(k) record. The listed applicant is Norton Performance Plastics Corp.. It received FDA 510(k) clearance on 1980-04-24 under 510(k) number K800619. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMODILUTION CATHETER INTRO. KIT?

THERMODILUTION CATHETER INTRO. KIT is a medical device that received FDA 510(k) clearance on 1980-04-24. The listed applicant is Norton Performance Plastics Corp.. The 510(k) number is K800619.

When did THERMODILUTION CATHETER INTRO. KIT receive FDA 510(k) clearance?

THERMODILUTION CATHETER INTRO. KIT received FDA 510(k) clearance on 1980-04-24, under 510(k) number K800619.

Who is the listed applicant for THERMODILUTION CATHETER INTRO. KIT?

The FDA 510(k) record lists Norton Performance Plastics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERMODILUTION CATHETER INTRO. KIT?

The FDA product code for THERMODILUTION CATHETER INTRO. KIT is DYB.

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Other records listing Norton Performance Plastics Corp. 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.

K853791NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000K852914ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSIONK851299CORRECT FLOK842858FLUID ADMINISTRATION LINE W/SPIKE 14-923K841828CENTRAL VENOUS CATHETER W/BIG-GARDK840240MICROFUSE INTRAVENOUS CATHETER SET

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Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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