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FDA 510(k)

HEPARIN-COATED EXTRACORPOREAL CIRCUITS

K-Number: K861641 · 1986-09-29

ApplicantAmerican Bentley
Decision Date1986-09-29
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEPARIN-COATED EXTRACORPOREAL CIRCUITS is the device name listed in this FDA 510(k) record. The listed applicant is American Bentley. It received FDA 510(k) clearance on 1986-09-29 under 510(k) number K861641. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEPARIN-COATED EXTRACORPOREAL CIRCUITS?

HEPARIN-COATED EXTRACORPOREAL CIRCUITS is a medical device that received FDA 510(k) clearance on 1986-09-29. The listed applicant is American Bentley. The 510(k) number is K861641.

When did HEPARIN-COATED EXTRACORPOREAL CIRCUITS receive FDA 510(k) clearance?

HEPARIN-COATED EXTRACORPOREAL CIRCUITS received FDA 510(k) clearance on 1986-09-29, under 510(k) number K861641.

Who is the listed applicant for HEPARIN-COATED EXTRACORPOREAL CIRCUITS?

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

What is the FDA product code for HEPARIN-COATED EXTRACORPOREAL CIRCUITS?

The FDA product code for HEPARIN-COATED EXTRACORPOREAL CIRCUITS is DTZ.

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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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