FDA 510(k)

EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC

K-Number: K924163 · 1993-09-03

Decision Date1993-09-03

Product CodeDRF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1993-09-03 under 510(k) number K924163. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC?

EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC is a medical device that received FDA 510(k) clearance on 1993-09-03. The listed applicant is Boston Scientific Corp. The 510(k) number is K924163.

When did EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC receive FDA 510(k) clearance?

EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC received FDA 510(k) clearance on 1993-09-03, under 510(k) number K924163.

Who is the listed applicant for EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC?

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

What is the FDA product code for EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC?

The FDA product code for EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC is DRF.

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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.