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FDA 510(k)

SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD

K-Number: K874465 · 1988-05-25

ApplicantAbbott Laboratories
Decision Date1988-05-25
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1988-05-25 under 510(k) number K874465. 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 SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD?

SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD is a medical device that received FDA 510(k) clearance on 1988-05-25. The listed applicant is Abbott Laboratories. The 510(k) number is K874465.

When did SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD receive FDA 510(k) clearance?

SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD received FDA 510(k) clearance on 1988-05-25, under 510(k) number K874465.

Who is the listed applicant for SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD?

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

What is the FDA product code for SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD?

The FDA product code for SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD is DYG.

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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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