FDA 510(k)

NORTON FLOW DIRECTED THERMODILUTION CATH

K-Number: K820229 · 1982-02-12

ApplicantNorton Performance Plastics Corp.

Decision Date1982-02-12

Product CodeDYG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

NORTON FLOW DIRECTED THERMODILUTION CATH 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 1982-02-12 under 510(k) number K820229. The device is classified under product code DYG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORTON FLOW DIRECTED THERMODILUTION CATH?

NORTON FLOW DIRECTED THERMODILUTION CATH is a medical device that received FDA 510(k) clearance on 1982-02-12. The listed applicant is Norton Performance Plastics Corp.. The 510(k) number is K820229.

When did NORTON FLOW DIRECTED THERMODILUTION CATH receive FDA 510(k) clearance?

NORTON FLOW DIRECTED THERMODILUTION CATH received FDA 510(k) clearance on 1982-02-12, under 510(k) number K820229.

Who is the listed applicant for NORTON FLOW DIRECTED THERMODILUTION CATH?

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 NORTON FLOW DIRECTED THERMODILUTION CATH?

The FDA product code for NORTON FLOW DIRECTED THERMODILUTION CATH is DYG.

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Other records listing Norton Performance Plastics Corp. as applicant

K853791NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 K852914ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION K851299CORRECT FLO K842858FLUID ADMINISTRATION LINE W/SPIKE 14-923 K841828CENTRAL VENOUS CATHETER W/BIG-GARD K840240MICROFUSE INTRAVENOUS CATHETER SET

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Related Devices (Code: DYG)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.