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FDA 510(k)

FLOW-DIRECTED HEPARIN COATED THERMODIL

K-Number: K832957 · 1983-09-29

ApplicantSorensen Research
Decision Date1983-09-29
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLOW-DIRECTED HEPARIN COATED THERMODIL is the device name listed in this FDA 510(k) record. The listed applicant is Sorensen Research. It received FDA 510(k) clearance on 1983-09-29 under 510(k) number K832957. 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 FLOW-DIRECTED HEPARIN COATED THERMODIL?

FLOW-DIRECTED HEPARIN COATED THERMODIL is a medical device that received FDA 510(k) clearance on 1983-09-29. The listed applicant is Sorensen Research. The 510(k) number is K832957.

When did FLOW-DIRECTED HEPARIN COATED THERMODIL receive FDA 510(k) clearance?

FLOW-DIRECTED HEPARIN COATED THERMODIL received FDA 510(k) clearance on 1983-09-29, under 510(k) number K832957.

Who is the listed applicant for FLOW-DIRECTED HEPARIN COATED THERMODIL?

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

What is the FDA product code for FLOW-DIRECTED HEPARIN COATED THERMODIL?

The FDA product code for FLOW-DIRECTED HEPARIN COATED THERMODIL is DYG.

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Other records listing Sorensen Research as applicant

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K833674ACCURATE MEASUREMENT DEVICE KG-AMDK833673ACCURATE MEASUREMENT DEVICE EZ-AMDK833094TRANSDUCER DOME SD104K833096TRANSDUCER DOME DS106K833095TRANSDUCER DOME SD105K831506DISP. TRANSDUCER W/MONITORING KIT TRANS

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Related Devices (Code: DYG)

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.

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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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